A tubular flow device (10) for enabling controlled flow of a fluid at a measuring point comprises an inlet flow channel (14) defining a main inflow direction, and an outlet flow channel (18) defining a main outflow direction. The flow device (10) further comprises a branching portion (22) where the inlet flow channel (14) is divided into a primary flow channel (24) and a secondary measurement channel (26), and a joining portion (36) where the primary flow channel (24) and the secondary measurement channel (26) open into the outlet flow channel (18). The measuring point is located in the secondary measurement channel (26). The primary flow channel (24) is longer than the secondary measurement channel (26) and has a constriction (42) downstream of the branching portion (22). A fluid entering the inlet flow channel (14) is divided into a primary flow flowing into the primary flow channel (24) and a secondary measurement flow flowing into the secondary measurement channel (26). The primary flow and the secondary measurement flow reach the joining portion (36) essentially at the same time, due to the Venturi effect caused by the constriction (42) of the primary flow channel (24).
B33Y 80/00 - Produits obtenus par fabrication additive
G01F 1/661 - Mesure du débit volumétrique ou du débit massique d'un fluide ou d'un matériau solide fluent, dans laquelle le fluide passe à travers un compteur par un écoulement continu en mesurant la fréquence, le déphasage, le temps de propagation d'ondes électromagnétiques ou d'autres types d'ondes, p. ex. en utilisant des débitmètres à ultrasons en utilisant la lumière
G01F 5/00 - Mesure d'une fraction du débit volumétrique
G01F 15/00 - Détails des appareils des groupes ou accessoires pour ces derniers, dans la mesure où de tels accessoires ou détails ne sont pas adaptés à ces types particuliers d'appareils, p. ex. pour l'indication à distance
G01F 1/50 - Moyens de correction ou de compensation
G01F 15/14 - Revêtements, p. ex. avec un matériau spécial
2.
A METHOD OF PRODUCING DIFFERENTIATED CELLS FROM PLURIPOTENT STEM CELLS, CELL POPULATIONS OBTAINED BY THE METHOD, CORRESPONDING PHARMACEUTICAL COMPOSITIONS AND A SYSTEM FOR PRODUCING DIFFERENTIATED CELLS FROM PLURIPOTENT STEM CELLS
The present invention inter alia relates to a method of producing differentiated cells from pluripotent stem cells, comprising providing at least one multicellular 3D aggregate derived from pluripotent stem cells cultured in a first suspension culture, inducing differentiation of the cells forming the at least one multicellular 3D aggregate, allowing a continuous release of differentiated cells from the multicellular 3D aggregate into the first suspension culture; and continuously separating the released differentiated cells from the first suspension culture. The present invention also relates to a cell obtained by the method and to a pharmaceutical composition comprising the cells. The invention further relates to a corresponding system for producing differentiated cells from pluripotent stem cells.
A bioprocess assembly (10) comprises a separation system (12) and a sampling system (14). The sampling system (14) is fluidically connected to the separation system (12) and comprises a sampling membrane (32) such that the separation system (12) and the sampling membrane (32) provide a separate sampling channel (30). The sampling channel (30) comprises at least one fluidic connection (36) to receive a buffer and at least one fluidic connection (51) to a sampling station (50). Further, the sampling channel (30) comprises a counter pressure generating unit (48) and at least one sensor (40), wherein the counter pressure generating unit (48) is configured to adjust the pressure within the sampling channel (30) based on data collected by the at least one sensor (40).
C12M 1/34 - Mesure ou test par des moyens de mesure ou de détection des conditions du milieu, p. ex. par des compteurs de colonies
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
G01N 1/20 - Dispositifs pour prélever des échantillons à l'état liquide ou fluide pour matériau coulant ou s'éboulant
4.
DEVICE ASSEMBLY AND METHOD FOR A PRODUCTION-SCALE TANGENTIAL FLOW FILTRATION
A device assembly (10) for performing a production scale tangential flow filtration of a feed, preferably in a batch feed and bleed process, comprises a first loop (12) including a first tubing (20), a feed tank (22) and actuators and sensors adapted to the first tubing (20), and a second loop (14) including second tubing (28) and a filter (28), preferably a hollow fiber filter. The first loop (12) and the second loop (14) further include a common tubing section. The first loop (12) connects to the second loop (14) at a first connection point (16) upstream, or alternatively downstream, of the filter (28), and the second loop (14) connects to the first loop (12) at a second connection point (18) downstream, or alternatively upstream, of the filter (28), such that the first loop (12) supplies the feed from the feed tank (22) to the second loop (14) at the first connection point (16), or alternatively at the second connection point (18), and the second loop (14) supplies retentate to the first loop (12) at the second connection point (18) from where a part of the retentate is returned to the feed tank (22), or alternatively at the first connection point (14). At least all wetted parts of the device assembly (10) are single-use parts and the inner diameter of the first tubing (20) is smaller than the inner diameter of the second tubing (32).
C12M 3/06 - Appareillage pour la culture de tissus, de cellules humaines, animales ou végétales, ou de virus avec des moyens de filtration, d'ultrafiltration, d'osmose inverse ou de dialyse
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
C12N 15/00 - Techniques de mutation ou génie génétiqueADN ou ARN concernant le génie génétique, vecteurs, p. ex. plasmides, ou leur isolement, leur préparation ou leur purificationUtilisation d'hôtes pour ceux-ci
5.
METHOD OF OPERATING A BIOPROCESS ARRANGEMENT TO PERFORM AT LEAST ONE REPETITION OF A BIOPROCESS
The invention relates to a method of operating a bioprocess arrangement (1) to perform at least one repetition of a bioprocess, wherein the bioprocess arrangement (1) comprises at least one replaceable electronic component (8), wherein a process control system (7) controls the bioprocess arrangement (1), using a digital model (10). It is proposed that the replaceable electronic components (8) are removed and replaced by new electronic components (9), that the process control system (7) automatically detects the removal of the replaceable electronic components (8), automatically detects the presence of the new electronic components (9) and retrieves digital representations (11) of the new electronic components (9) based on the communication with the new electronic components (9), that the process control system (7) derives from the digital representations (11) of the replaceable electronic components (8) and the new electronic components (9) a functional relationship between the replaceable electronic components (8) and the new electronic components (9), that the process control system (7) replaces the digital representations (11) of the replaceable electronic components (8) with the digital representations (11) of the new electronic components (9) based on the functional relationship thereby updating the digital model (10), and, that the process control system (7) controls the bioprocess arrangement (1) to perform the bioprocess based 20 on the updated digital model (10).
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
6.
METHOD OF HARVESTING CELL BROTH, AND MIXING DEVICE
A method of harvesting cell broth (12) from a mixing device (10) for mixing the cell broth (12) of a rocking motion bioreactor is shown. The mixing device (10) comprises a rocking motion platform (14), a mixing bag (18) and a processing unit (22). After a harvest process is started, the mixing bag (18) is tilted into a default harvest position and the cell broth (12) is harvested in the default harvest position of the mixing bag (18). If a pause condition is fulfilled, harvesting is paused and the mixing device starts rocking at a defined speed and a defined rocking angle for a predetermined time. After the predetermined time, harvesting in the default harvest position is resumed. Furthermore, a mixing device (10) for mixing cell broth (12) is disclosed.
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
C12M 3/06 - Appareillage pour la culture de tissus, de cellules humaines, animales ou végétales, ou de virus avec des moyens de filtration, d'ultrafiltration, d'osmose inverse ou de dialyse
C12M 1/34 - Mesure ou test par des moyens de mesure ou de détection des conditions du milieu, p. ex. par des compteurs de colonies
B01F 27/80 - Mélangeurs à agitateurs tournant dans des récipients fixesPétrins avec des agitateurs tournant autour d'un axe sensiblement vertical
7.
METHOD OF CONTROLLING A BIOPHARMACEUTICAL PURIFICATION PROCESS
A method of controlling a biopharmaceutical purification process, preferably a continuous process, making use of a separation arrangement. The separation arrangement preferably includes multiple chromatography columns or filtration devices. The method comprises the following steps: repeatedly acquiring an absorption spectrum inline or online at a fluid stream with a detector which is capable of recording spectra within a wavelength range between 190 nm and 2400 nm, preferably between 190 nm and 390 nm or 190 nm and 780 nm or 1100 nm and 2400 nm; real-time processing of the acquired spectrum; and real- time monitoring and controlling the process based on the processed spectrum. The step of processing includes at least one of the following measures: reducing noise; reducing spectral interference; correcting the acquired spectrum for scattering effects and/or other background effects.
G01N 30/88 - Systèmes intégrés d'analyse, spécialement adaptés à cet effet, non couverts par un seul des groupes
B01D 15/18 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives aux différents types d'écoulement
8.
METHOD AND DEVICE FOR AUTOMATING THE FOAM CONTROL IN A BIOREACTOR
The invention relates to a method for automating the foam regulation during a bioprocess for cultivating cells in a bioreactor, said method comprising the following steps: determining values of one or more process variables of the bioprocess which is/are relevant for the formation of foam in the bioreactor; transferring the determined values as input signals to a controller; generating, by the controller, output signals for at least one foam regulation device depending on the input signals; and controlling the at least one foam regulation device in a requirements-oriented manner by means of the output signals output by the controller.
C12M 1/34 - Mesure ou test par des moyens de mesure ou de détection des conditions du milieu, p. ex. par des compteurs de colonies
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
9.
COUPLING DEVICE FOR COUPLING TO A DIAPHRAGM DEVICE, DIAPHRAGM DEVICE AND METHOD
A coupling device (1) for coupling to a flexible diaphragm (51) of a diaphragm device (50) and comprising a base structure (10) for attaching the diaphragm device (50) thereto; an actuator structure (20) mounted movable along an actuation direction (A) relative to the base structure (10) and having a diaphragm grasping element (22) pivotably mounted between a release position and a grasping position for coupling the actuator structure (20) to the flexible diaphragm (51) in the grasping position; and a fixation structure (30) mounted movable along a fixation direction (F) relative to the base structure (10) between an open position and a closed position and designed to fix in the closed position the diaphragm grasping element (22) against leaving the grasping position.
F16K 1/48 - Fixation des corps de soupapes aux tiges des soupapes
F16K 7/16 - Dispositifs d'obturation à diaphragme, p. ex. dont un élément est déformé, sans être déplacé entièrement, pour fermer l'ouverture à diaphragme plat, en forme d'assiette ou en forme de bol disposé pour être déformé contre un siège plat le diaphragme étant actionné mécaniquement, p. ex. par une tige filetée ou par came
F16L 37/127 - Accouplements du type à action rapide dans lesquels l'assemblage entre les extrémités s'aboutant ou se chevauchant est maintenu par des organes de blocage utilisant des crochets, cliquet, ou autres organes de blocage mobiles ou que l'on peut insérer utilisant des crochets articulés autour d'un axe
10.
METHOD FOR PERFORMING A TANGENTIAL FLOW FILTRATION ON A BIOMOLECULAR SOLUTION
The invention relates to a method for performing a tangential flow filtration on a biomolecular solution, in particular for performing a single pass tangential flow filtration on a biomolecular solution, as part of a production process for biomolecules, wherein a tangential flow filtration arrangement (1) is provided, wherein the tangential flow filtration arrangement (1) comprises a tangential flow filtration module (2), wherein the tangential flow filtration is performed inside the tangential flow filtration module (2), wherein the tangential flow filtration module (2) comprises a filter (3), a feed input fluid line (4) for the biomolecular solution as a feed medium, a retentate output fluid line (6) for a retentate, a filtrate output fluid line (7) for a filtrate, and preferably a buffer input fluid line (5) for a buffer, wherein the tangential flow filtration arrangement (1) comprises at least two actuators (8) influencing the tangential flow filtration, wherein the tangential flow filtration arrangement (1) comprises a control module (10), wherein the control module (10) controls the tangential flow filtration by providing control signals to the actuators (8) and measuring at least two measured variables (11) describing the tangential flow filtration, wherein the control module (10) uses a process control to control the tangential flow filtration. It is proposed that the process control is a model predictive control (13), that the control module (10) inputs the measured variables (11) as input variables (14) into the model and derives at least two manipulated variables (15) as control signals for the actuators (8).
The invention relates to a device for continuous virus inactivation during a protein production process, in particular an antibody production process, wherein the device comprises an axially extending hollow-body holder (1) for holding an elongated, elastically deformable hollow body (2), in particular a flexible tube, wherein the device comprises at least two axially extending rollers (3, 4), in particular three or four rollers (3, 4, 5, 6), each of which, when the device has been assembled as intended, squeezes the hollow body (2) and thereby divides the internal volume (7) of the hollow body (2) into volume portions (8) fluidically separated from one another, wherein the continuous virus inactivation is carried out in the volume portions (8) of the hollow body (2). It is proposed that the device comprises a support element (9) which, when the device has been assembled as intended, supports the lateral faces of each of the rollers (3, 4, 5, 6) in at least one point.
C12M 1/12 - Appareillage pour l'enzymologie ou la microbiologie avec des moyens de stérilisation, filtration ou dialyse
A61L 2/00 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet
C12N 7/00 - Virus, p. ex. bactériophagesCompositions les contenantLeur préparation ou purification
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
B01D 15/24 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives au traitement des fractions à répartir
12.
METHOD OF OPERATING A BIOPROCESSING ARRANGEMENT COMPRISING A CLARIFICATION SET-UP TO REMOVE CELL DEBRIS FROM A CELL BROTH
The invention relates to a method of operating a bioprocessing arrangement (1) comprising a clarification set-up (2) to remove cell debris from a cell broth (10), wherein the clarification set-up (2) comprises a fluidized bed centrifuge (8) with at least one centrifuge chamber (11), wherein the cell broth (10) is separated into at least a waste fraction (12) and an output fraction (13), wherein the separation of the cell broth (10) into the waste fraction (12) and the output fraction (13) comprises a loading step (14) during which the centrifuge chamber (11) is loaded with cells of the cell broth (10) up to a capacity below or equal to a maximum cell loading capacity of the centrifuge chamber (11), an overloading step (15) during which the centrifuge chamber (11) is further loaded with cell broth (10), thereby flushing out cells from the centrifuge chamber (11), collecting cells flushed out during the overloading step (15) as the waste fraction (12), and collecting cells from the chamber as the output fraction (13).
The invention relates to a an aeration device for a bioprocessing installation (2), comprising a housing (4), a circumferential rigid body (5), wherein the housing (4) comprises at least a first aeration channel (7) and a second aeration channel (8), wherein the housing (4) further comprises at least a first gas inlet port (10) and a second gas inlet port (11), and wherein the housing (4) further comprises a plurality of first gas discharge openings (12) and second gas discharge openings (13). It is proposed that the first aeration channel (7) and the second aeration channel (8) are arranged so as to overlap one another in the axial direction at least in sections.
B01F 23/231 - Mélange de gaz avec des liquides en introduisant des gaz dans des milieux liquides, p. ex. pour produire des liquides aérés par barbotage
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
14.
FILTRATION DEVICE, IN PARTICULAR SMALL-SCALE FILTRATION DEVICE FOR PRODUCTION OF BIOPHARMACEUTICALS
A filtration device (10), in particular a small-scale filtration device for production of biopharmaceuticals, comprises a housing including a top cover (12) having an unfiltrate inlet (18) and a bottom cover (14) having a filtrate outlet (22), and one or more filter supports (16) stacked between the top cover (12) and the bottom cover (14) along a vertical direction such that an upper side of each filter support (16) faces the top cover (12) and a lower side of each filter support (16) faces the bottom cover (14). Each filter support (16) is equipped with a flat upper filter (40) and a flat lower filter (42). Each filter (40, 42) has a filtrate side and an opposite unfiltrate side. The upper and lower filters (40, 42) are sealed to the upper and lower sides of the filter support (16), respectively, with the filtrate sides facing the filter support (16) and the unfiltrate sides facing away from the filter support (16). Unfiltrate flow paths lead from the unfiltrate inlet of the top cover (12) to the unfiltrate side of the upper filter (40) and to the unfiltrate side of the lower filter (42), wherein blocking means prevent unfiltrate from flowing directly from the unfiltrate inlet of the top cover (12) to the filtrate outlet (22) of the bottom cover (14). Filtrate flow paths lead from the filtrate sides of the upper and lower filters (40, 42) to the filtrate outlet (22) of the bottom cover (14) via at least one filtrate guiding channel (48a, 48b) formed on the upper side of the filter support (16) and at least one filtrate guiding channel (48a, 48b) formed on the lower side of the filter support (16). The upper filter (40) and the lower filter (42) are identically shaped.
C12M 3/06 - Appareillage pour la culture de tissus, de cellules humaines, animales ou végétales, ou de virus avec des moyens de filtration, d'ultrafiltration, d'osmose inverse ou de dialyse
B01D 69/10 - Membranes sur supportSupports pour membranes
The present invention relates to a method for treating an ultrafiltration membrane, a method for producing an ultrafiltration membrane comprising the treatment method, as well as ultrafiltration membrane obtained by the treatment method or the production method.
The invention relates to a portable container holder for use in a bioprocess for holding and transporting a disposable container (3) which is filled with a fluid (2) and which has received a magnetically driven mixing element (4) for mixing the fluid (2), wherein the portable container holder (1) has a container receiving area (7) for receiving the disposable container (3), said receiving area having a drive location (8) where the mixing element (4) can be arranged in the disposable container (3) received in the container receiving area (7) such that the mixing element (4) can be driven by a drive unit (9) at the drive location (8). According to the invention, the portable container holder (1) has a transport securing unit (11) for securing and releasing the mixing element (4), which is arranged at the drive location (8), in its position, and the transport securing unit (11) has a magnet (10) which can be moved between a defined securing position (12), in which the mixing element (4) is secured in its position, and a defined release position (13), in which the mixing element (4) is released from its position.
The invention relates to a portable container holder for use in a bioprocess for holding and transporting a flexible disposable container (3) which is filled with a fluid (2). In particular, the fluid (2) is a fluid (2) which contains a purified pharmaceutical ingredient or a cultivation medium, and the portable container holder (1) has a container receiving area (6) for receiving the disposable container (3) and a cover (7) which can be installed on the container receiving area (6) in order to cover (7) the disposable container (3) received in the container receiving area (6), wherein the cover (7) has a fixing assembly (8) via which the disposable container (3) filled with the fluid (2) can be fixed in the container receiving area (6) in the installed state of the cover (7). According to the invention, the cover (7) has a spring assembly (9) which elastically supports the fixing assembly (8), and a spring force can be applied to the fixing assembly (8) in the direction of the spring via the spring assembly (9) in the installed state of the cover (7).
The invention relates to a bioprocess system for a bioprocess operation with a display arrangement (21) for displaying system information about the bioprocess system (1), wherein the bioprocess system (1) comprises system components (6) comprising at least one monitored system component (22), wherein the system components (6) can be assembled into an assembled state in which the bioprocess system (1) is operational for the bioprocess operation and can be disassembled into a disassembled state in which the bioprocess system (1) is not operational for the bioprocess operation, wherein the bioprocess system (1) comprises a control arrangement (24) and the display arrangement (21) comprises at least one display component (25), wherein in an assembled state of the bioprocess system (1) during a bioprocess operation the control arrangement (24) displays process information via the display arrangement (21) and/or wherein during assembly of the bioprocess system (1) the control arrangement (24) displays assembly information via the display arrangement (21), wherein the process information and/or the assembly information concern at least the monitored system component (22) and wherein the display arrangement (21) comprises at least one display component (25). It is proposed that the display component (25) comprises a light emitting element (27) arranged separate from the monitored system component (22) and arranged next to or on the monitored system component (22) and that the control arrangement (24) is configured to display via the light emitting element (27) the process information and/or the assembly information relating to the monitored system component (22).
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
G05B 19/409 - Commande numérique [CN], c.-à-d. machines fonctionnant automatiquement, en particulier machines-outils, p. ex. dans un milieu de fabrication industriel, afin d'effectuer un positionnement, un mouvement ou des actions coordonnées au moyen de données d'un programme sous forme numérique caractérisée par l'utilisation de l'entrée manuelle des données [MDI] ou par l'utilisation d'un panneau de commande, p. ex. commande de fonctions avec le panneauCommande numérique [CN], c.-à-d. machines fonctionnant automatiquement, en particulier machines-outils, p. ex. dans un milieu de fabrication industriel, afin d'effectuer un positionnement, un mouvement ou des actions coordonnées au moyen de données d'un programme sous forme numérique caractérisée par les détails du panneau de commande ou par la fixation de paramètres
G06F 9/448 - Paradigmes d’exécution, p. ex. implémentation de paradigmes de programmation
G05B 19/40 - Systèmes à boucle ouverte, p. ex. utilisant un moteur pas à pas
G05B 19/042 - Commande à programme autre que la commande numérique, c.-à-d. dans des automatismes à séquence ou dans des automates à logique utilisant des processeurs numériques
The invention relates to a method for inactivating viruses in a fluid, in which method: a starting fluid (AF) containing active viruses is mixed with a virus-inactivating reagent (R1) in a first mixing assembly (2) to form a reactive fluid (F); the active viruses are inactivated via incubation of the reactive fluid (F); and the inactivation of the viruses in the reactive fluid (F) is stopped by mixing the reactive fluid (F) with a further reagent (R2) or by removing the virus-inactivating reagent (R1) from the reactive fluid (F), as a result of which a resulting fluid (RF) is produced. According to the invention, the active viruses are inactivated via incubation of the reactive fluid (F) in a container assembly (3) which comprises a plurality of separate containers (4) and differs from the first mixing assembly (2), wherein the reactive fluid (F) is conducted from the first mixing assembly (2) to the container assembly (3) prior to incubation.
A61L 2/00 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet
The invention relates to a method for generating and purifying viral vectors (V), wherein the viral vectors (V) are generated by cells in a fluid (F) and wherein the fluid (F) comprising the viral vectors (V) is guided through a tangential flow filtration arrangement (2) for purification, whereby the viral vectors (V) are purified in the fluid (F). It is proposed that the cells and cell debris from the cells, which are contained in the fluid (F) comprising the viral vectors (V) after generating the viral vectors (V), are at least partially separated from the viral vectors (V) by a fluidized bed centrifuge (5) before purification by the tangential flow filtration arrangement (2).
C12N 7/00 - Virus, p. ex. bactériophagesCompositions les contenantLeur préparation ou purification
C12N 15/00 - Techniques de mutation ou génie génétiqueADN ou ARN concernant le génie génétique, vecteurs, p. ex. plasmides, ou leur isolement, leur préparation ou leur purificationUtilisation d'hôtes pour ceux-ci
The present invention relates to methods for the purification of viruses, virus-like particles, extracellular vesicles, proteins having a diameter of 5 nm or more, protein complexes having a diameter of 5 nm or more, nucleic acids having a diameter of 5 nm or more, protein-nucleic acid complexes having a diameter of 5 nm or more, and/or molecules having a diameter of 5 nm or more, by filtration-supported polyalkylene glycol precipitation, and to filtration modules that can be used in said methods.
The invention relates to a method for operating a continuous downstream process, in particular a continuous virus activation or inline dilution process, using a bio-process arrangement (1), wherein the bio-process arrangement (1) has a compensating container (2) with a first fluid inlet (3), configured for introduction of a concentrate stream, in particular a product or buffer concentrate stream, into the compensating container (2), with at least one second fluid inlet (4), configured for introduction of a diluent stream, in particular a product or buffer diluent stream, into the compensating container (2), with a fluid outlet (5), configured to discharge a liquid stream from the compensating container (2), wherein the bio-process arrangement (1) has a conveying arrangement (6) for fluid conveyance, which is allocated to the first fluid inlet (3) and to the second fluid inlet (4) for conveying in each case at least one liquid stream into the compensating container (2), and is allocated to the fluid outlet (5) for conveying a liquid stream out of the compensating container (2), and wherein the bio-process arrangement (1) has an electronic process control (7). It is proposed that the electronic process control (7) adapts, by controlling the conveying arrangement (6) in an open-loop and/or closed-loop manner, a fill level in the compensating container (2) such that a predefined minimum fill level in the compensating container (2) is always reached.
B01F 23/40 - Mélange de liquides avec des liquidesÉmulsion
B01F 35/83 - Formation d'un rapport prédéterminé des substances à mélanger en commandant le rapport entre plusieurs débits, p. ex. en utilisant des dispositifs de détection ou de commande du débit
B01F 35/221 - Commande ou régulation des paramètres de fonctionnement, p. ex. du niveau de matière dans le mélangeur, de la température ou de la pression
24.
METHOD FOR PERFORMING AN INTEGRITY TEST ON A TESTING CONSUMABLE OF A BIOPROCESS INSTALLATION
The invention relates to a method for performing an integrity test on a testing consumable (1) of a bioprocess installation using a test arrangement (2), wherein during a test routine (26), which is being performed by a test control unit (3) of the test arrangement (2), a predetermined test procedure is being applied to the testing consumable (1) via the test arrangement (2) and an integrity state is being derived from process data that have been collected during the test routine (26). It is proposed that during the test routine (26), early process data (27), that are being generated by a testing sensor arrangement (4) of the test arrangement (2) in an early stage of the test procedure, are being used to determine the integrity state of the testing consumable (1) by correlating in a correlating step (28) the early process data (27) to a system model (29) of a reference module (30), which reference module (30) emulates a, in particular integral, testing consumable (1) only in view of predetermined process data.
C12M 1/12 - Appareillage pour l'enzymologie ou la microbiologie avec des moyens de stérilisation, filtration ou dialyse
B01D 65/10 - Test de membranes ou d'appareils à membranesDétection ou réparation de fuites
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
G01M 3/22 - Examen de l'étanchéité des structures ou ouvrages vis-à-vis d'un fluide par utilisation d'un fluide ou en faisant le vide par détection de la présence du fluide à l'emplacement de la fuite en utilisant des révélateurs particuliers, p. ex. teinture, produits fluorescents, produits radioactifs pour tuyaux, câbles ou tubesExamen de l'étanchéité des structures ou ouvrages vis-à-vis d'un fluide par utilisation d'un fluide ou en faisant le vide par détection de la présence du fluide à l'emplacement de la fuite en utilisant des révélateurs particuliers, p. ex. teinture, produits fluorescents, produits radioactifs pour raccords ou étanchéité de tuyauxExamen de l'étanchéité des structures ou ouvrages vis-à-vis d'un fluide par utilisation d'un fluide ou en faisant le vide par détection de la présence du fluide à l'emplacement de la fuite en utilisant des révélateurs particuliers, p. ex. teinture, produits fluorescents, produits radioactifs pour soupapes
G01N 15/08 - Recherche de la perméabilité, du volume des pores ou de l'aire superficielle des matériaux poreux
25.
HOLDING DEVICE FOR A CONTAINER, HAVING A MAGNETIC DRIVE FOR A SEPARATE AGITATOR SHAFT
The invention relates to a holding device (26) for a container, in particular a bioreactor, comprising a magnetic drive (30) for a separate agitator shaft (28) and a lever device (10) for releasing the agitator shaft (28) from the magnetic drive (30). The magnetic drive (30) has a first coupling side (32) and the agitator shaft (28) has a second coupling side (34) of a magnetic coupling, said second coupling side being connectable to the first coupling side (32). The lever device (10) has at least one pressure portion (22; 64) and is pivotable between a closing position and a release position. As the lever device (10) is pivoted into the release position, the pressure portion (22; 64) is moved downwards in order to act directly or indirectly on the agitator shaft (28).
B01F 33/453 - Mélangeurs magnétiquesMélangeurs avec agitateurs à entraînement magnétique en utilisant des éléments d'agitation supportés ou suspendus
B01F 27/213 - Mélangeurs à agitateurs tournant dans des récipients fixesPétrins caractérisés par leurs arbres de rotation caractérisés par la liaison avec l'entraînement
26.
METHOD FOR OPERATING A BIOPROCESS INSTALLATION FOR PRODUCTION OF A BIOPRODUCT
The invention relates to a method for operating a bioprocess installation (1) for production of a bioproduct, wherein the bioprocess installation (1) comprises a source receptacle (2) for cell cultivation, a harvest receptacle (3) for bioproduction and a clarification setup (4) with a centrifuge (12), wherein the source receptacle (2) is operated in a cyclical production mode comprising the steps of: a) starting the cyclical production mode in the source receptacle (2) b) cultivating the cells in the source receptacle (2), thereby obtaining a cell broth (7) comprising cultivated cells, c) discharging a discharge fraction (16) of the cell broth (7) from the source receptacle (2), d) combining a restart fraction (17) of the cell broth (7) with fresh cultivation medium (8) and repeating step b), e) repeating steps c) and d) at least once and/or f) discharging the cell broth (7) obtained from step d) from the source receptacle (2) stopping the cyclical production mode, obtaining a discharge fraction (16), wherein the method further comprises the steps of: i) centrifuging the discharge fraction (16) via the centrifuge (12), thereby separating the discharge fraction (16) into at least a centrifuged discharge fraction (19) and supernatant (14) and preferably bioproduct, ii) operating the harvest receptacle (3) in a production mode, wherein steps i) and ii) are executed at least twice.
C12M 1/107 - Appareillage pour l'enzymologie ou la microbiologie avec des moyens pour recueillir les gaz de fermentation, p. ex. le méthane
C12M 1/34 - Mesure ou test par des moyens de mesure ou de détection des conditions du milieu, p. ex. par des compteurs de colonies
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
The invention relates to a method for a dynamic in-line mixing process of a pressurized medium (1), which contains a liquid and at least one additional liquid or solid constituent, in a bioprocess assembly (3). The liquid is combined with the at least one additional liquid or solid constituent in a specified volume ratio at an opening point (4) in order to form a resulting liquid flow (5), wherein the bioprocess assembly (3) has a pump assembly (8) with a first pump (9), the first pump (9) is arranged in the line (7) of the line assembly (6), the first pump (9) is designed as a rotary pump (10), in particular a centrifugal pump, which is designed for a dynamic in-line mixing process of the medium (1), the first pump (9) has a liquid inlet (9a) which forms the suction side of the pump when operated as intended and a liquid outlet (9b) which forms the pressure side of the pump when operated as intended, and the medium (1) is conducted through the rotary pump (10) for a dynamic in-line mixing process. According to the invention, the medium flows through the rotary pump (10) in the opposite flow direction, in comparison to the intended operation, for the dynamic in-line mixing process.
Disclosed is inter alia a method for validating a filter unit, wherein the method comprises: - guiding a fluid flow of a fluid, after the fluid flow passed through the filter unit, to a measurement area that is connected to the filter unit, wherein within the measurement area the fluid is exposed to at least one alternating electric field between at least two electrodes; - obtaining at least one electric signal between the at least two electrodes, wherein the at least one electric signal is at least affected by whether one or more cells of a plurality of cells in the fluid pass through the measurement area; and - determining, at least partially based on the obtained at least one electric signal, at least one validity information indicating a validity of the filter unit.
A bioreactor system (10) for carrying out a biological process comprises a container (12) for receiving a liquid biological medium and a gas supply facility for feeding various gases from gas sources (38, 40, 42, 44) into the container (12) in a controlled manner. The gas supply facility has a plurality of gas outlet lines (28, 30, 32) which open into one or more gas supply devices (20) and/or into an overlay gas outlet in the interior of the container (12). Each gas outlet line (28, 30, 32) is connected to multiple gas sources (38, 40, 42, 44) by a respective gas supply line (46, 52, 56, 58) or by a respective branch (48, 50, 54, 60) of a gas supply line (46, 52, 56, 58). A mass flow regulator (62), which is connected to a control unit, is arranged in each gas supply line (46, 52, 56, 58) and in each branch (48, 50, 54, 60). Such a bioreactor system for carrying out a biological process preferably comprises a controller, which comprises a master regulator for a controlled variable, at least one sensor associated with the master regulator and one or more follower regulators with actuators (14, 62), the manipulated variables of which influence the controlled variable in a targeted manner. The controller is designed such that a setpoint value for the controlled variable can be prespecified to the master regulator, the at least one sensor is used for repeated determination of an actual value of the controlled variable, and the master regulator provides to the follower regulators an output signal dependent upon the deviation of the actual value of the controlled variable from the setpoint value of the controlled variable. Control profiles, which are dependent upon the output signal of the master regulator, are assigned to the follower regulators. According to a first alternative, the control profiles contain setpoint values for the actuators (14, 62) of the follower regulators, and the controller is designed such that the setpoint values for the actuators (14, 62) can be input in the physical unit of their manipulated values. According to a second alternative, the control profiles contain setpoint values for a parameter that relates directly to the biological process and can be influenced in a targeted manner by the actuators (14, 62), and the controller is designed such that it automatically assigns setpoint values for the actuators of the follower regulators to the parameter setpoint values.
The invention relates to a flow-through centrifuge (1), which can be used for example for biotechnological applications, in particular in the form of a blood centrifuge (2). A drive and/or transmission assembly (19) of the through-flow centrifuge (1) has a planetary transmission (62). At least one planetary belt pulley (34; 36) is rotatably mounted on a rotating planet carrier (18) in the planetary transmission (62), and the torque of the planetary belt pulley (34; 36) is transmitted via a belt (33; 37), wherein the planet carrier (18) and the belt pulley (34; 36) are driven at different rotational speeds. According to the invention, the planet carrier (18) is held via a belt-tensioning unit (17) which rotates together with the planet carrier (18), and the distance (42) between the planet carrier (18) and a rotor axis (4) can be modified via the belt-tensioning unit (17) in order to set the tension of the belt (33; 37).
The invention is directed to a method for producing a roll (1) or sheet of membrane units (2) for a membrane product (3) such as a lateral flow test from a roll (6) or sheet of membrane material (7), by means of a primary production arrangement (9), wherein the roll (6) or sheet of membrane material (7) is processed into a roll (1) or sheet of membrane units (2) in a primary processing routine, wherein in the primary processing routine, for generating the membrane units (2), a fluidic structure (11), in particular a hydrophobic structure, for defining fluid flow through the membrane material (7) is introduced into the membrane material (7) by means of a processing tool (12), wherein an evaluation routine is performed by means of an evaluation arrangement (15) comprising a sensor arrangement (16) and an evaluation control (17). It is proposed that in the evaluation routine, evaluation images (18) of the fluidic structures (11) of the membrane units (2) are generated by means of the sensor arrangement (16) and evaluation data (19) are generated by means of the evaluation control (17) and that the evaluation data (19) represent the deviation in predefined geometrical properties of the fluidic structure (11) in the respective evaluation image (18) with respect to the fluidic structure (11) in a reference image (21).
The present invention relates to automated nanoparticle synthesis systems and computer-implemented methods of monitoring and controlling a process of manufacturing lipid nanoparticles (LNPs) containing nucleic acid cargo. The present invention furthermore relates to a computer program product comprising computer-readable instructions, which, when loaded and executed on a computer system, causes the computer system to perform operations according to said methods.
The invention relates to a centrifuge (19), in particular a continuous-flow centrifuge, a biotechnical centrifuge or a blood centrifuge. The centrifuge (19) is provided with a coolant circuit (1). According to the invention, the outlet side of a controllable compressor (4) is connected to an inlet side of an evaporator (2) via a bypass line (5) with a valve (20) arranged therein. In a normal operating mode, when the valve (20) is closed, the cooling of a centrifuge bowl (3) occurs exclusively via the control of the compressor (4) and an expansion unit (6). However, if the target temperature in the centrifuge bowl (3) falls below a tolerance range, the valve (20) is opened in order to bring about a heating process and thereby a returning of the temperature in the centrifuge bowl (3) to within the tolerance range.
The present invention relates to tangential flow filtration/chromatography systems, the use thereof, and methods of separation, particularly simultaneously separating one or more target molecules from cells, cell debris and further contaminants contained in e.g. fermentation broth or any other particulate and impurity containing, non-clarified liquid.
B01D 15/22 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives à la structure de la colonne
The present invention relates to a filter module comprising an ester-based membrane and at least one boundary member, wherein the peripheral region of the membrane is connected to the at least one boundary member, and wherein the surface of the membrane is saponified in the regions other than the peripheral region connected to the at least one boundary member. Further, the present invention relates to a method of producing such filter module and to the use of such filter module.
B01D 65/00 - Accessoires ou opérations auxiliaires, en général, pour les procédés ou les appareils de séparation utilisant des membranes semi-perméables
The application relates to a sensor holding device for holding a sensor device, in particular a clamp-on flow measurement sensor, the sensor holding device comprising: a holding body configured for holding the sensor device, wherein the holding body comprises: a sensor holding device-side engaging means for engaging with a sensor device-side engaging means of the sensor device when the sensor device is held by the holding body; and a securing means connected to the holding body for securing the sensor device at the holding body, the securing means being moveable relative to the holding body to a first position and to a second position, wherein the securing means moved into the first position allows placing the sensor device onto the holding body and removing the sensor device from the holding body, and wherein the securing means moved into the second position and the sensor holding device-side engaging means engaging the sensor device-side engaging means restrict relative movement of the sensor device along three directions with respect to the holding body such that the sensor device is secured at the holding body.
The present invention relates to a filter system, which can be used as a clarification filter/depth filter for cell culture clarification before chromatography and/or ultrafiltration for protein purification, as well as to a method of separating cells and other contaminants from a fluid containing one or more target components by employing the filter system of the present invention.
B01D 15/12 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives à la préparation de l'alimentation
B01D 15/38 - Adsorption sélective, p. ex. chromatographie caractérisée par le mécanisme de séparation impliquant une interaction spécifique non couverte par un ou plusieurs des groupes , p. ex. chromatographie d'affinité, chromatographie d'échange par ligand ou chromatographie chirale
A bioreactor for cell cultivation comprises a reusable reactor vessel (16), preferably made of stainless steel, for receiving a fluid, and an optical spectroscopy interface (14) including an adapter (10) and a single-use optical spectroscopy insert (12). The reusable reactor vessel (16) has a wall (18) and a port formed in the wall (18). The adapter (10) is configured to be fixed to the port in a predefined position at the port. The single-use optical spectroscopy insert (12) is configured to be accommodated and fixed in the adapter (10), or the insert (12) is an integral part of the adapter (10).
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
39.
SYSTEM FOR DETECTING A MEASUREMENT VARIABLE OF A FLUID BEING CONDUCTED IN A FLUID-CONDUCTING LINE, FLOW-THROUGH DEVICE FOR ARRANGING ON A FLUID-CONDUCTING LINE AND FOR ATTACHING A FLOWMETER, AND USE OF A FLOW-THROUGH DEVICE
The invention relates to a system for detecting a measurement variable of a fluid being conducted in a fluid-conducting line, said system having: - a flowmeter, in particular an ultrasonic flow meter, for detecting the measurement variable, - a flow-through device (10) for arranging on the fluid-conducting line and for attaching the flowmeter for detecting the measurement variable of the fluid being conducted by the line, said flowmeter having: - a first and second connection (12, 14), by means of which the flow-through device (10) can be connected to the fluid-conducting line, and - a measurement region (16) which is arranged between the first connection (12) and the second connection (14) and which can be coupled to the flowmeter for detecting the measurement variable, wherein the first connection (12), the measurement region (16), and the second connection (14) define a flow path (A) for the fluid through the flow-through device (10), and the measurement region (16) has at least two contact surfaces (20), which extend at least partly along the flow path (A), for contacting the flowmeter. The at least two contact surfaces (20) are designed to separate a coupling means under the effect of a pressing force, and the flowmeter is designed so as to exert at least the pressing force onto the at least two contact surfaces (20) by means of a coupling of the flowmeter to the measurement region (16). The invention additionally relates to a flow-through device and to a use thereof.
G01F 1/667 - Dispositions de transducteurs pour les débitmètres à ultrasonsCircuits pour faire fonctionner les débitmètres à ultrasons
G01F 1/66 - Mesure du débit volumétrique ou du débit massique d'un fluide ou d'un matériau solide fluent, dans laquelle le fluide passe à travers un compteur par un écoulement continu en mesurant la fréquence, le déphasage, le temps de propagation d'ondes électromagnétiques ou d'autres types d'ondes, p. ex. en utilisant des débitmètres à ultrasons
G01F 15/00 - Détails des appareils des groupes ou accessoires pour ces derniers, dans la mesure où de tels accessoires ou détails ne sont pas adaptés à ces types particuliers d'appareils, p. ex. pour l'indication à distance
G01F 15/18 - Supports ou moyens de raccordement pour les compteurs
40.
METHOD OF REFERENCING AN ANALYTE MEASUREMENT IN A PURIFICATION SYSTEM
In a method of referencing an analyte measurement in a purification system during a process step in a biopharmaceutical process, the following sub-steps are performed during the same process step: guiding a medium through a purification unit (10) where the analyte is either removed from or added to the medium; measuring at least one parameter related to the presence and/or quantity of the analyte with a first measurement system (16) at a first measurement location upstream of the purification unit (10); measuring the at least one parameter with a second measurement system (18) at a second measurement location downstream of the purification unit (10); and referencing the upstream measurement to the downstream measurement, or referencing the downstream measurement to the upstream measurement.
DEVICE FOR ARRANGING ON A FLUID-CONDUCTING LINE AND FOR ATTACHING A FLOWMETER, AND METHOD FOR DETECTING A MEASUREMENT VARIABLE OF THE FLUID BEING CONDUCTED BY A LINE
The invention relates to a device (10) for arranging on a fluid-conducting line and for attaching a flowmeter, in particular an ultrasonic flowmeter, for detecting a measurement variable of the fluid being conducted by the line, having: - a first and a second connection (12, 14), by means of which the device (10) can be connected to the fluid-conducting line, - a measurement region (16) which is arranged between the first connection (12) and the second connection (14) and which can be coupled to the flowmeter in order to detect the measurement variable, wherein the first connection (12), the measurement region (16), and the second connection (14) define a flow path (A) for the fluid through the device (10), and - a flow-influencing element (22) which is arranged in and/or on the flow path (A) and which is arranged in front of the measurement region (16) in a provided flow direction of the fluid along the flow path (A) and at a distance therefrom. The flow-influencing element (22) is integrally formed with the first connection (12) or the second connection (14), and the flow-influencing element (22) is designed such that the flow flowing into the device (10) via the first connection (12), said fluid flowing into the device (10) with a substantially laminar flow, has a substantially turbulent flow in the measurement region (16).
G01F 1/66 - Mesure du débit volumétrique ou du débit massique d'un fluide ou d'un matériau solide fluent, dans laquelle le fluide passe à travers un compteur par un écoulement continu en mesurant la fréquence, le déphasage, le temps de propagation d'ondes électromagnétiques ou d'autres types d'ondes, p. ex. en utilisant des débitmètres à ultrasons
G01F 1/667 - Dispositions de transducteurs pour les débitmètres à ultrasonsCircuits pour faire fonctionner les débitmètres à ultrasons
G01F 15/00 - Détails des appareils des groupes ou accessoires pour ces derniers, dans la mesure où de tels accessoires ou détails ne sont pas adaptés à ces types particuliers d'appareils, p. ex. pour l'indication à distance
G01F 15/18 - Supports ou moyens de raccordement pour les compteurs
F15D 1/02 - Action sur l'écoulement des fluides dans les tuyaux ou les conduits
42.
MULTIPORT DEVICE FOR CONNECTING A LOOP TO ONE PORT OF A BIOREACTOR, AND PERFUSION OR CONCENTRATED FED-BATCH SETUP FOR PERFORMING AN UPSTREAM PROCESS OF CELL CULTURE
A multiport device (42) for connecting a loop (36), preferably a tangential flow filtration loop or a sensor loop, to one port (34) of a bioreactor (32), preferably a single-use bioreactor (32), is configured to be fixed to the port (34) of the bioreactor (32). The multiport device (42) includes a first flow path (44) configured for 5 withdrawing fluid from the bioreactor (32), and a second flow path (52) configured for supplying fluid to the bioreactor (32). The first flow path (44) has a first end (48) adapted to be in fluid connection with the bioreactor (32), and a second end (50) adapted to be connected to an inlet of the loop (36). The second flow path (52) has an outer end (64) adapted to be connected to an outlet of the loop (36), and a 10 mouth (62) adapted to be in fluid connection with the bioreactor (32). The mouth (62) of the second flow path (52) is distanced from the first end (48) of the first flow path (44) by at least 5 mm, preferably 10 mm.
A device assembly (10) for calibrating a single-use sensor (14) before, during or after a biopharmaceutical manufacturing process step comprises a single-use process equipment assembly for performing at least a part of the process step. The single-use process equipment assembly includes a flow line (12) through which a medium flows in a defined direction during the process step. The single- use process equipment assembly further includes an integrated single-use sensor (14) for measuring or detecting a physical or chemical property at a measurement location in the flow line (12). The device assembly (10) further comprises at least one calibration line (18) and at least one switching means (22) inserted into the flow line (12) upstream of the measurement location. The switching means (22) include a flow line inlet, a flow line outlet and a calibration line inlet connected to the calibration line (18). The switching means (22) are adapted to selectively switch between a first (main) flow path, in which the flow line inlet (26) and the flow line outlet (28) are opened while the calibration line inlet (30) is closed, and a second (calibration) flow path, in which the flow line inlet (26) is closed while the calibration line inlet (30) and the flow line outlet (28) are opened. The device assembly (10) comprises a dedicated reference means provided in the calibration line (18). The dedicated reference means includes a reference sensor (48) or a reference source or a reference standard solution (40) related to the physical or chemical property to be measured or detected by the single-use sensor (14). The calibration line (20) may also be provided downstream of the single-use sensor (14).
A modular system for providing a bioprocess device assembly comprises a rigid skid (10) and a plurality of grid-modules (12). The skid (10) includes a plurality of identical plug-in structures (14) being arranged in a regular two-dimensional grid. The grid arrangement of the plug-in structures (14) defines two-dimensional plug-in fields (20) of an identical standard shape and size. At least some of the grid- modules (12) have a matching counterpart plug-in structure (22) adapted to fix the respective grid-module (12) to any of the plug-in structures (14) of the skid (10). At least some of the grid-modules (12), in an installed state when fixed to a plug-in structure (14) of the skid (10) and/or to a neighboring grid-module (12), have a two- dimensional extension in the plane of the grid that is not greater than the standard size of the plug-in fields (20). At least some of the grid-modules (12) include at least one connection port (30) adapted to receive a rigid universal flow connector (26; 34) of standard shape and size in a standard position and orientation. The universal flow connector (26; 34) establishes a flow connection between two neighboring grid-modules (12). The connection port (30) of each grid-module (12) defines the standard position and orientation of the universal flow connector (26; 34) such that, in its installed state, the grid-module (12) can be connected via the universal flow connector (26; 34) either directly to the connection port (30) or to another universal flow connector (34) received in the connection port (30) of an opposing grid-module (12) fixed to the grid-module (12) and/or to a neighboring plug-in structure (14). At least some of the grid-modules (12) have at least one integrated fluid line (32) through, or into, which a medium to be processed or analyzed can flow. The integrated fluid line (32) is in flow communication with the connection port (30) of the grid-module (12). The plurality of grid-modules (12) includes at least one flow control grid-module having means for actively changing flow properties of the medium, and/or at least one interaction grid-module having means for sensing, detecting or measuring a property of the medium.
C12M 3/00 - Appareillage pour la culture de tissus, de cellules humaines, animales ou végétales, ou de virus
B01L 9/02 - Paillasses ou tables de laboratoireLeurs garnitures
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
45.
SYSTEMS AND METHODS INVOLVING CONTROLLED OXYGEN RELEASE IN BIOMATERIALS
Some aspects of the disclosure are related to systems and methods for controlled oxygen release from biomaterials in vessels and unit operations or components of cell culture, cell containment, and/or bioreactor. Vessels, unit operations, devices, and/or components of the invention may be used to perform all or part of a biological and/or chemical process involving biologicals (e.g., a plurality of cells) in the presence of oxygen-releasing agents. In some embodiments, a system comprises a vessel comprises an oxygen-releasing agent configured to generate in- situ and release oxygen in a sustained manner. The presence of an oxygen-releasing agent may advantageously allow for high cell density fermentation and cell cultivation in a vessel and provide an alternative for supplemental gassing means (e.g., sparger, etc.). Some embodiments of the disclosure are directed to employing the oxygen-releasing agents in microfluidic or millifluidic systems.
The present invention relates to a separation system for separating and purifying a target component, a method for separating and purifying a target component, and the use of a single-pass crossflow diafiltration unit for integrally connecting a first and a second chromatography device.
B01D 15/18 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives aux différents types d'écoulement
B01D 15/36 - Adsorption sélective, p. ex. chromatographie caractérisée par le mécanisme de séparation impliquant une interaction ionique, p. ex. échange d'ions, paire d'ions, suppression d'ions ou exclusion d'ions
B01D 61/04 - Prétraitement du courant d'alimentation
B01D 15/24 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives au traitement des fractions à répartir
B01D 61/16 - Prétraitement du courant d'alimentation
47.
CONTAINERS INCLUDING INTERNAL MIXERS AND METHODS OF USE
Containers including internal mixers and actuators assemblies and related methods are generally described. In some embodiments, a container may include a mixer and an actuator, at least one of which may be located inside of the container. The actuator may actuate the mixer to induce flow within the container and mix the contents of the container with a low volumetric footprint and high mixing efficiency. In some embodiments, the actuator may be configured to deform the mixer, which may include one or more features which may be deformed out of plane in a Kirigami or Origami fashion. The actuator and mixer may be arranged in series or in parallel. The actuator may be used without a mixer to induce flow within the container. The actuator may be driven pneumatically, hydraulically, electrically, and/or in any other suitable manner.
B01F 31/55 - Mélangeurs avec mécanismes à secousses, oscillants ou vibrants les matières à mélanger étant contenues dans un sac souple soumis à une déformation périodique
B65D 83/00 - Réceptacles ou paquets comportant des moyens particuliers pour distribuer leur contenu
B01F 31/441 - Mélangeurs avec mécanismes à secousses, oscillants ou vibrants avec des agitateurs effectuant un mouvement oscillatoire, vibratoire ou de secousses effectuant un mouvement rectiligne de va-et-vient
B01F 35/513 - Récipients souples, p. ex. sacs supportés par des conteneurs rigides
B01F 31/44 - Mélangeurs avec mécanismes à secousses, oscillants ou vibrants avec des agitateurs effectuant un mouvement oscillatoire, vibratoire ou de secousses
B65D 75/36 - Objets ou matériaux enveloppés entre deux feuilles ou flans opposés à bords réunis, p. ex. par adhésifs à pression, pliage, thermosoudage ou soudage une ou les deux feuilles ou flans étant renfoncés pour épouser la forme du contenu une feuille ou un flan étant renfoncés et l'autre fait d'une feuille plate relativement rigide, p. ex. empaquetage pour ampoules
Kirigami mixing systems and related methods are generally described. In some embodiments, a mixing system includes one or more grippers configured to deform a portion of a flexible container containing fluid when undergoing axial deformation. The grippers may include features including slots, hinges, and spines to aid in the transition of the grippers between a closed and retracted configuration when the one or more grippers are deformed. The compression of the container subsequently result in fluid flow within the container which may mix or agitate the fluid. In some embodiments, the described grippers may be formed integrally with the flexible containers. In some embodiments, the mixing system may include a plurality of grippers arranged around the flexible container.
B01F 31/55 - Mélangeurs avec mécanismes à secousses, oscillants ou vibrants les matières à mélanger étant contenues dans un sac souple soumis à une déformation périodique
Different types of plastics (4, 7, 10), present in biologically contaminated products (20) of heterogenous composition, are separated based on specificities regarding melt viscosity and/or melting temperature, preferably using at least one melt filter. In a pre-processing unit (50), the solid products are subjected to size reduction, to obtain size-reduced parts (2). After heating of at least the plastic materials contained in the size-reduced parts, a molten mixture is obtained, including two types of plastics having specific melt viscosities and/or melting temperatures that are different. Then, in a separation equipment typically including an extruder, at least one of the two types of plastics is selectively separated from the molten mixture, as unfiltered part relative to a melt filter, the unfiltered part essentially or only containing a type of polymer that is sterilized, preferably due to said heating, and collected in a collection container (5, 8, 11).
Different types of plastics (4, 7, 10), present in biologically contaminated filtering devices (20) of heterogenous composition, are separated based on specificities regarding melt viscosity and/or melting temperature, preferably using at least one melt filter. In a preprocessing unit (50), the solid products are subjected to size reduction, to obtain size-reduced parts (2). After heating of at least the plastic materials contained in the size-reduced parts, a molten mixture is obtained, including two types of plastics having specific melt viscosities and/or melting temperatures that are different. Then, in a separation equipment (150) typically including an extruder (100), at least one of the two types of plastics (4, 7, 10) is selectively separated from the molten mixture, as unfiltered part relative to a melt filter, so that the unfiltered part may be collected as valuable material in a collection container (5, 8, 11).
The present invention relates to a separation system for separating and purifying a target component, a method for separating and purifying a target component, and the use of a crossflow diafiltration unit for processing a target phase, which is obtained after separation of an aqueous two-phase system and contains a target component.
A smart single-use tube line assembly (10) for use in a unit operation of a bioprocess comprises at least one tube line (16, 18). The tube line (16, 18) includes a tube body (22) surrounding a lumen (24) through which a medium can flow. The tube line assembly (10) also comprises a functional element (12, 14) embedded in the tube body (22), the functional element (12, 14) being configured to perform an optical and/or electrical function. The tube line assembly (10) further comprises an interface (26) for coupling both the lumen (24) and the functional element (12, 14) of the tube line (16, 18) to another component. The tube line assembly (10) still further comprises a control unit for controlling the optical and/or electrical function.
The invention relates to technical solutions for monitoring or controlling bioprocesses by way of withdrawing discrete fluid samples from a reactor and performing on-line analysis of said sample using a fluidic manifold, for example, by means of a sensor based in particular on label-free biomolecular interaction analysis. The invention particularly relates to a system for measuring one or more analytes in discrete fluid samples from a vessel adapted to contain a fluid comprising one or more sensors (5) for the measurement of the analytes (53) in a contact volume of the fluid sample, an analysis module (65) comprising at least one main sampling line in fluidic connection with the vessel and one or more pumps in fluidic connection with said main sampling line(s) and adapted to selectively pump fluid from in the main sampling line away from the vessel, at least one fluid distribution tubing (30) in fluidic connection with the analysis module, a manifold (20) comprising a body (25), and in the body (25), for each sensor (5), one fluidic cell comprising one fluid distribution channel (21) and a collecting channel (22a, 22b) in fluidic communication with the fluid distribution channel (21), wherein the fluid distribution tubing (30) is fitted in the fluid distribution channel (21) so that it is emerging in the collecting channel (22) and so that the sensor (5) can be contacted with at least a drop (10) of the fluid sample emerging at the top of the fluid distribution tubing (30) as the contact volume or wherein the fluid distribution tubing (30) is fitted in the fluid distribution channel (21) in fluidic connection with a measurement well (40), so the measurement well (40) can be filled with the fluid sample to create the contact volume and the sensor (5) can be dipped in the contact volume for measurement, and wherein said collecting channels (22a, 22b) are plunging so the fluid sample is collected per gravity.
G01N 1/14 - Dispositifs d'aspiration, p. ex. pompesDispositifs d'éjection
G01N 1/18 - Dispositifs pour prélever des échantillons à l'état liquide ou fluide avec mesures prises pour diviser des échantillons en plusieurs parties
B01L 3/00 - Récipients ou ustensiles pour laboratoires, p. ex. verrerie de laboratoireCompte-gouttes
C12M 1/32 - Inoculateur ou échantillonneur du type à champs multiples ou en continu
G01N 1/00 - ÉchantillonnagePréparation des éprouvettes pour la recherche
G01N 21/77 - Systèmes dans lesquels le matériau est soumis à une réaction chimique, le progrès ou le résultat de la réaction étant analysé en observant l'effet sur un réactif chimique
G01N 35/00 - Analyse automatique non limitée à des procédés ou à des matériaux spécifiés dans un seul des groupes Manipulation de matériaux à cet effet
G01N 1/10 - Dispositifs pour prélever des échantillons à l'état liquide ou fluide
The invention is directed to a method for producing a bioproduct using a bioprocess installation (1 ), wherein the bioprocess installation (1) comprises an electronic process control (2) and a bioprocess unit (3), wherein the bioprocess unit (3) comprises a receptacle (4), a clarification unit (5) with a centrifuge (6) and a chromatography unit (8) with a chromatograph (10), wherein cell broth obtained from the receptacle (4) is being lead through the clarification unit (5) and the chromatography unit (8) sequentially in a liquid stream (9), wherein the clarification unit (5) with its centrifuge (6) is being operated in a centrifugation cycle comprising centrifugation steps, such as loading-, washing- and discharging-steps, wherein the chromatography unit (8) with its chromatograph (10) is being operated in a chromatography cycle comprising chromatography steps, such as equilibration-, loading-, washing-, elution- and regeneration¬ steps, It is proposed that particle depletion between the liquid stream section leaving the clarification unit (5) and the liquid stream section leaving the chromatography unit (8) is less than 10% in particle concentration and that the execution of the steps assigned to the centrifugation cycle and the execution of the steps assigned to the chromatography cycle are at least partly being synchronized with each other by the electronic process control (2) in synchronization routines (13) based on assigned synchronization strategies (14).
B01D 15/12 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives à la préparation de l'alimentation
C07K 1/36 - ExtractionSéparationPurification par une combinaison de plusieurs procédés de types différents
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
55.
DEVICE ARRANGEMENT AND METHOD OF SEPARATING CELLS FROM A CULTURE MEDIUM IN A BIOPROCESS
A device arrangement (10) for separation of cells from a culture medium in a bioprocess, especially in a biopharmaceutical process, comprises: a reservoir vessel (12) for the culture medium; a filtration module (16) having at least one membrane across which flow is possible; a feed conduit (24) that connects the reservoir vessel (12) to an unfiltrate inlet (18) of the filtration module (16) for supplying culture medium to the filtration module (16); a return conduit (26) that connects a retentate-side outlet (20) of the filtration module (16) to the reservoir vessel (12) for recycling retentate into the reservoir vessel (12); a filtrate conduit (28) connected to a permeate-side outlet (22) of the filtration module (16) for removal of filtrate; a first pump (30) for maintaining a recirculation flow; a backflush conduit (32) that leads to a permeate-side connection (33) and/or to the permeate-side outlet (22) of the filtration module (16) for feeding a flush liquid into the filtration module (16); and a second pump (34) for conveying the flush liquid into the filtration module (16). A method of separating cells from a culture medium (14) has the following steps: cultivating cells in a culture medium (14) in a bioreactor; filtering the culture medium (14) in a filtration module (16) having at least one membrane, wherein the culture medium (14) passes through a recirculation circuit; flushing the membrane with a flush liquid during the filtering, wherein the flush liquid is a buffer solution or water or substrate, and wherein the flushing introduces flush liquid into the recirculation circuit, especially in order to dilute the recirculating unfiltrate and simultaneously to clean the membrane of the filtration module (16) by detaching the covering layer deposited on the membrane in the course of the filtration.
The invention relates to a product for providing membrane elements, comprising: a carrier film; and a membrane film, at least comprising: a support layer; and a membrane layer; the membrane film is releasably coupled to the carrier film; and the membrane film has a plurality of substantially discrete membrane elements. The invention also relates to a corresponding manufacturing process.
B01L 3/00 - Récipients ou ustensiles pour laboratoires, p. ex. verrerie de laboratoireCompte-gouttes
B32B 43/00 - Opérations spécialement adaptées aux produits stratifiés et non prévues ailleurs, p. ex. réparationAppareils pour ces opérations
B32B 37/12 - Procédés ou dispositifs pour la stratification, p. ex. par polymérisation ou par liaison à l'aide d'ultrasons caractérisés par l'usage d'adhésifs
B32B 38/10 - Enlèvement de couches ou de parties de couches, mécaniquement ou chimiquement
B32B 38/00 - Opérations auxiliaires liées aux procédés de stratification
The invention relates to a method and a module for sterility testing based on optically analyzing at least one test liquid (3), which test liquid (3) is contained in a liquid container (4), wherein depending on the contamination state of the test liquid (3), non liquid contaminants (5) are distributed in the test liquid. It is proposed, that in an analyzing routine (9) performed by a control arrangement (6), image-related data (10) representing at least one optical image (I) of the test liquid (3), generated by a sensor arrangement (11), are being transmitted from the sensor arrangement (11) to the control arrangement (6) and the contamination state of the test liquid (3) is derived from the image-related data (10) based on the interrelation between the distribution characteristics of the contaminants (5) and the respective contamination state.
C12M 1/12 - Appareillage pour l'enzymologie ou la microbiologie avec des moyens de stérilisation, filtration ou dialyse
A61L 2/28 - Dispositifs pour tester l'efficacité ou l'intégralité de la stérilisation, p. ex. indicateurs qui changent de couleur
C12M 1/34 - Mesure ou test par des moyens de mesure ou de détection des conditions du milieu, p. ex. par des compteurs de colonies
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
Systems and methods for characterizing a plurality of particles suspended in a solution are described. In some embodiments, an ultrasonic interrogation signal may be emitted into a solution including a plurality of particles suspended in the solution. A resulting ultrasonic spectrum may be sensed and provided to a trained statistical model of the solution. The trained statistical model may then determine one or more properties of the plurality of particles.
The invention relates to a device for a continuous virus inactivation during a protein production process, comprising a first and a second fluid inlet (2, 3), each of which is designed to introduce a liquid flow into the device (1), comprising a first mixer (4), which is designed to mix a liquid flow, and comprising a fluid outlet (5), which is designed to discharge a liquid flow out of the device (1), wherein a first liquid flow (6) which contains a target protein can be introduced into the device (1) by the first fluid inlet (2) and can be combined with a second virus-inactivating liquid flow (7), which can be introduced into the device (1) by the second fluid inlet (3), in a precisely defined volume ratio in order to form a third reactive liquid flow (8) which is conducted through the first mixer (4) for mixing purposes in order to generate defined virus-inactivating conditions. According to the invention, the device (1) has a head part (9) for combining two liquid flows, one of which is the liquid flow (6) containing the target protein; the device (1) has a dwell time assembly (10), which is fluidically connected to the head part (9), downstream of the first mixer (4) and upstream of the fluid outlet (5) in order to provide a minimum dwell time of the third reactive liquid flow (8) within the device (1); the head part (9) and the dwell time assembly (10) are rigidly secured to each other; and end face of the head part (9) is arranged on the dwell time assembly (10).
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
B01F 25/42 - Mélangeurs statiques dans lesquels le mélange est affecté par le déplacement conjoint des composants dans des directions différentes, p. ex. dans des tubes munis de chicanes ou d'obstructions
B01F 25/43 - Tubes de mélange, p. ex. dans lesquels la matière est déplacée dans une direction radiale ou partiellement inversée
The invention is directed to a method for operating a bioprocess installation (1) with an electronic process control (2) and at least one bioprocess unit (3), wherein the bioprocess unit (3) comprises a cell broth source with a first receptacle (4) for cell broth including cultivation media and cells, establishing a culture environment (A, B) for cell cultivation and/or bio production, wherein the bioprocess unit (3) comprises a clarification setup (5) with a centrifuge (6) for the clarification of the cell broth by centrifugation, with a liquid pumping arrangement (7) assigned to the centrifuge (6) and with a liquid network (8) with a number of liquid lines (9) communicating with the liquid pumping arrangement (7), wherein out of a first culture environment (A) established by the first receptacle (4), the cell broth is transfered to the centrifuge (6) via the liquid network (8), which centrifuge (6) is operated in a forward operation for cell separation and/or cell washing and in a backward operation for cell discharging. It is proposed that the liquid network (8) comprises a recycling line (15) and that in the backward operation, at least part of the discharged cells are being transferred into a second culture environment (B) different from the first culture environment (A) via the recycling line (15) for subsequent cell cultivation and/or bioproduction.
The present disclosure relates to a method of measuring cell density in a cell suspension comprising cell aggregates, the method comprising (i) Measuring the permittivity of the cell suspension; (ii) Comparing the measured permittivity with a predetermined value that is indicative of the cell density, thereby determining the cell density. Further described is a of a permittivity probe for determining the cell density of a suspension cell culture comprising cell aggregates.
G01N 33/487 - Analyse physique de matériau biologique de matériau biologique liquide
G01N 27/22 - Recherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en recherchant l'impédance en recherchant la capacité
62.
METHOD OF CHANGING CULTURE MEDIUM OF A CULTURE USING SPINFILTERS
The present invention relates to a method of expanding stem cells cultured as cell aggregates in a suspension culture changing culture medium and a method of medium exchange for the same cells characterized in the use of a rotating mesh such as a spinfilter device. The present invention further relates to a use of a rotating mesh for medium exchange in a suspension culture of stem cells.
A device assembly for controlling an integrated continuous pharmaceutical or biopharmaceutical manufacturing process comprises: a first process equipment (10) adapted for performing a first process step; a second process equipment (20) adapted for performing a second process step subsequent to the first process step; a single measuring unit (24) adapted for measurement of at least one set of signals of a liquid process medium at a single location, the set of measured signals depending on at least a first parameter and a different second parameter; and an evaluation and control unit (28) adapted for evaluating the set of measured signals to determine a value of the first parameter and a value of the second parameter. The evaluation and control unit (28) is further adapted for determining a first corrective feedback based on the value of the first parameter and a different second corrective feedback based on the value of the second parameter. The evaluation and control unit (28) is further adapted for controlling the first process step by providing the first corrective feedback to the first process equipment (10) and for controlling the subsequent second process step by providing the second corrective feedback to the second process equipment (20).
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
Summarizing the invention, a method for testing integrity of a filter is provided. The method comprises: pressurizing an upstream side of the filter to a test pressure; performing a check step comprising: - determining a flow rate of fluid from the upstream side to a downstream side of the filter; - comparing the determined flow rate with a flow range including a flow threshold; - setting stop criteria based on the comparison, wherein the stop criteria comprise at least one quantitative constraint indicative of a reliability of the determined flow rate and wherein: if the determined flow rate is within the flow range, the stop criteria are set to first stop criteria; and if the determined flow rate is outside the flow range, the stop criteria are set to second stop criteria; - determining whether the stop criteria are satisfied; if the stop criteria are not satisfied, repeating the check step until the stop criteria are satisfied; if the stop criteria are satisfied, comparing the determined flow rate with the flow threshold: if the determined flow rate is greater than or equal to the flow threshold, determining that the filter is non-integral; and if the determined flow rate is less than the flow threshold, determining that the filter is integral.
The present invention relates to a chromatographic material comprising a polymer network material-based self-supporting bi-continuous separation matrix for adsorptive material separation in liquid media, and a method of producing the chromatographic material comprising a polymer network material-based self- supporting bi-continuous separation matrix.
B01J 20/24 - Composés macromoléculaires d'origine naturelle, p. ex. acides humiques ou leurs dérivés
B01J 20/28 - Compositions absorbantes ou adsorbantes solides ou compositions facilitant la filtrationAbsorbants ou adsorbants pour la chromatographieProcédés pour leur préparation, régénération ou réactivation caractérisées par leur forme ou leurs propriétés physiques
B01J 20/285 - Absorbants ou adsorbants poreux à base de polymères
B01J 20/291 - Absorbants ou adsorbants sous forme de gel
B01J 20/30 - Procédés de préparation, de régénération ou de réactivation
B01D 15/38 - Adsorption sélective, p. ex. chromatographie caractérisée par le mécanisme de séparation impliquant une interaction spécifique non couverte par un ou plusieurs des groupes , p. ex. chromatographie d'affinité, chromatographie d'échange par ligand ou chromatographie chirale
B01D 67/00 - Procédés spécialement adaptés à la fabrication de membranes semi-perméables destinées aux procédés ou aux appareils de séparation
The present invention relates in particular to a method and a device for an integrity test of a double filter capsule (10). The method comprises: - providing the double filter capsule (10), which has a housing (12) in which a first filter (18, 19) and a second filter (19, 20) are disposed, one downstream of the other in the flow direction of a medium (M) to be filtered, in such a way that in a filtration process the medium to be filtered flows in its flow direction from an upstream chamber (22, 23) in the housing (12) through the first filter (18, 19) into an intermediate chamber (23, 24) between the first filter (18, 19) and the second filter (19, 20) and then through the second filter (19, 20) to an outlet (16), the housing (12) having an upstream-chamber access point (44, 45) for feeding a test fluid (TG) into the upstream chamber (22, 23) and an intermediate-chamber access point (45, 46) for feeding the test fluid (TG) into the intermediate chamber (23, 24); - providing a connecting line (48) between the upstream-chamber access point (44, 45) and the intermediate-chamber access point (45, 46) for fluidic connection between the upstream chamber (22, 23) and the intermediate chamber (23, 24), at least the fluid connection toward the intermediate chamber (23, 24) being closable; and - determining the state of integrity of the double filter capsule (10) on the basis of at least the following two test phases: a first test phase, comprising feeding the test fluid (TG) into the upstream chamber (22, 23) while the fluid connection of the connecting line (48) toward the intermediate chamber (23, 24) is closed, and carrying out a first integrity test; and a second test phase, comprising simultaneously feeding the test fluid (TG) into the upstream chamber (22, 23) and via the intermediate-chamber access point (45, 46) into the intermediate chamber (23, 24) while the upstream chamber (22, 23) is fluidically connected to the intermediate chamber (23, 24) via the connecting line (48) such that pressure is equalized between the upstream chamber (22, 23) and the intermediate chamber (23, 24), and carrying out a second integrity test.
G01N 15/08 - Recherche de la perméabilité, du volume des pores ou de l'aire superficielle des matériaux poreux
A61L 2/02 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des phénomènes physiques
B01D 65/10 - Test de membranes ou d'appareils à membranesDétection ou réparation de fuites
B01D 29/58 - Filtres à éléments filtrants stationnaires pendant la filtration, p. ex. filtres à aspiration ou à pression, non couverts par les groupes Leurs éléments filtrants à plusieurs éléments filtrants caractérisés par leur agencement relatif montés en série disposés de façon concentrique ou coaxiale
B01D 29/11 - Filtres à éléments filtrants stationnaires pendant la filtration, p. ex. filtres à aspiration ou à pression, non couverts par les groupes Leurs éléments filtrants avec des éléments filtrants en forme de sac, de cage, de tuyau, de tube, de manchon ou analogue
67.
METHOD FOR ENSURING MICROBIOLOGICAL PURITY OF A SINGLE-USE DEVICE, AND COVER FOR A FLUID CONNECTION OF A SEPARATION UNIT FOR USE IN SUCH A METHOD
In a method for ensuring microbiological purity of a single-use device (10) for carrying out a biotechnological process, the single-use device (10) comprises at least one gamma-sterilisable component, which is formed from materials suitable for sterilisation using gamma radiation, and at least one sub-component, which is not gamma-sterilisable and contains material unsuitable for sterilisation using gamma radiation. Both the component and the sub-component each have a region that, when the biotechnological process is being carried out, comes into contact with a process medium. The method comprises the following steps: a) sterilising the gamma-sterilisable component using gamma radiation; b) protecting the medium-contacting region of the gamma-sterilisable component using a sterile barrier; c) sterilising the sub-component that is not gamma-sterilisable using superheated steam; d) protecting the medium-contacting region of the sub-component that is not gamma-sterilisable using a sterile barrier; e) removing the sterile barriers; and f) installing the gamma-sterilised component and the superheated-steam-sterilised sub-component in the single-use device (10) immediately after removing the sterile barriers.
A61L 2/07 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des phénomènes physiques de la chaleur des gaz chauds de la vapeur
A61L 2/08 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des phénomènes physiques des radiations
B01D 65/02 - Nettoyage ou stérilisation de membranes
B01D 15/20 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives au conditionnement de la matière adsorbante ou absorbante
Summarizing the invention, a chromatography system is provided. The chromatography system is configured to process a feed fluid containing a plurality of components, wherein at least one component of the plurality of components of the feed fluid is a target component. The chromatography system comprises: a flow path comprising a plurality of fluid control components configured to control a fluid flow; a stationary phase, wherein the stationary phase is at least one membrane adsorber connected to the flow path and the stationary phase is configured to isolate the target component. The flow path is configured such that harvesting of the target component is optimized.
B01D 15/14 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives à l'introduction de l'alimentation dans l'appareil
B01D 15/22 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives à la structure de la colonne
B01D 15/24 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives au traitement des fractions à répartir
B01D 69/02 - Membranes semi-perméables destinées aux procédés ou aux appareils de séparation, caractérisées par leur forme, leur structure ou leurs propriétésProcédés spécialement adaptés à leur fabrication caractérisées par leurs propriétés
B01D 15/12 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives à la préparation de l'alimentation
The invention relates to a computer-implemented method for configuring and/or setup and/or controlling of a downstream process for processing a biomass, comprising: receiving at least one measurement value of at least one feature of an upstream process by which the biomass to be processed in the downstream process has been obtained and/or of at least one feature of a downstream process stage or operation; determining at least one downstream process parameter based on the received at least one measurement value; arid configuring and/or setup and/or controlling at least one downstream process stage or process operation based on the determined at least one downstream process parameter. The invention further relates to a computer-program product and a system for configuring and/or setup and/or controlling of a downstream process, a method and a system for processing a biomass.
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
Fluidic modules configured for flowing fluid through membranes and associated methods are generally provided. In some embodiments, a fluidic module comprises two channels between which a membrane is positioned. The two channels may have geometries such that the pressure drop experienced by a fluid flowing from the first channel, through the membrane, and into the second channel is substantially independent of the location along the channel at which it flows through the membrane. In other words, the pressure drop may be substantially constant over the membrane area.
A distributor assembly (14) which is provided in particular for a separation unit (12) of a modular process device arrangement (10) comprises a fluid distributor means having multiple fluid ports (28, 30), wherein the fluid distributor means can selectively form and block flow connections between the fluid ports (28, 30). The distributor assembly (14) also comprises a connection element (42) and a securing element (58). The connection element (42) can be attached to one of the fluid ports (30), and the distributor assembly (14) has an associated installation socket (60) at the fluid port (30). The installation socket (60) is adapted to the shape of the securing element (58) such that the securing element (58) can be inserted into the installation socket (60) up to a defined securing position in which the securing element (58) engages with the connection element (42) and fixes it in place.
F16L 41/03 - Ensembles de branchements, p. ex. d'une seule pièce, soudés à l'autogène, rivetés comportant des pièces d'assemblage pour quatre tuyaux ou plus
F16L 37/14 - Raccords par insertion d'un élément entre surfaces à unir, p. ex. par un bout de fil, une goupille, une chaîne
B01D 35/00 - Dispositifs filtrants ayant des particularités non couvertes spécifiquement par les groupes , applications non couvertes spécifiquement par les groupes Dispositifs auxiliaires pour la filtrationStructure du carter de filtre
B01D 65/00 - Accessoires ou opérations auxiliaires, en général, pour les procédés ou les appareils de séparation utilisant des membranes semi-perméables
The invention relates to a modular device for fixedly arranging and interconnecting individual separation units (12) and/or first function units (74) amongst one another to carry out one or more basic operations in a biotechnological process. The modular device comprises a plurality of distributor caps (14), of which at least one distributor cap (14) is intended for mounting on a separation unit (12) and one or more further distributor caps (14) are each intended for mounting on a further separation unit (12) or a first function unit (74). The distributor caps (14) each have the following: a fluid distribution device with a working port (28) and at least two feed or discharge ports (30), the fluid distribution device being able to assume at least two defined switch positions; port means for producing a fluidic connection between a fluid inlet or outlet (34; 34a, 34b) of the separation units (12) or first function unit (74) and the working port (28) of the fluid distribution device; connection means for producing a rigid mechanical connection and a fluidic connection to an adjacent distributor cap (14); and an interface for changing the switch positions of the fluid distribution device manually or in automated fashion.
B01D 65/00 - Accessoires ou opérations auxiliaires, en général, pour les procédés ou les appareils de séparation utilisant des membranes semi-perméables
B01D 35/147 - Soupapes de dérivation ou de sécurité
The present invention relates to a digital control unit of a bioprocess arrangement (2) for controlling a bioprocess, wherein the digital control unit (1) comprises a local data storage (4) and a local processor unit (5), wherein the digital control unit (1) comprises a bioprocess interface (6) for sending and receiving bioprocess control data, wherein the digital control unit (1) is configured to execute a bioprocess control routine (19) via the local processor unit (5) to control the bioprocess, wherein in the bioprocess control routine (19), the digital control unit (1) generates bioprocess data (16) from the actuator data (8) and/or the sensor data (12) and/or the user control command data (18). It is proposed that the digital control unit (1) is configured to execute a signing routine (24) via the local processor unit (5) and that in the signing routine (24), the digital control unit (1) digitally signs documentation data (23), derived from the bioprocess data 16, by generating a digital signature (26).
H04L 29/06 - Commande de la communication; Traitement de la communication caractérisés par un protocole
G06F 21/57 - Certification ou préservation de plates-formes informatiques fiables, p. ex. démarrages ou arrêts sécurisés, suivis de version, contrôles de logiciel système, mises à jour sécurisées ou évaluation de vulnérabilité
G06F 21/64 - Protection de l’intégrité des données, p. ex. par sommes de contrôle, certificats ou signatures
H04L 9/32 - Dispositions pour les communications secrètes ou protégéesProtocoles réseaux de sécurité comprenant des moyens pour vérifier l'identité ou l'autorisation d'un utilisateur du système
G06Q 10/06 - Ressources, gestion de tâches, des ressources humaines ou de projetsPlanification d’entreprise ou d’organisationModélisation d’entreprise ou d’organisation
G16H 10/40 - TIC spécialement adaptées au maniement ou au traitement des données médicales ou de soins de santé relatives aux patients pour des données relatives aux analyses de laboratoire, p. ex. pour des analyses d’échantillon de patient
H04L 29/08 - Procédure de commande de la transmission, p.ex. procédure de commande du niveau de la liaison
G16H 70/40 - TIC spécialement adaptées au maniement ou au traitement de références médicales concernant des médicaments, p. ex. leurs effets secondaires ou leur usage prévu
The present invention is directed to a method for conducting a bioprocess with a digital control unit (1) of a bioprocess arrangement (2), wherein the digital control unit (1) comprises a local data storage (4) and a local processor unit (5), wherein bioprocess data (16) are generated by the digital control unit (1). It is proposed, that in a data safety routine (21), a documentation routine (22) and a signing routine (24) are executed, that in the documentation routine (22), documentation data (23) are generated from the bioprocess data (16) and that in the signing routine (24), a cryptographic private key (25) is extracted from private key data (20) and the documentation data (23) are digitally signed with the cryptographic private key (25) by generating a digital signature (26) and that the documentation routine (22) is executed continuously during the bioprocess and that the signing routine (24) is executed discontinuously during the bioprocess in several signing cycles according to a signing strategy (P), which defines trigger events (ei) for initiating the signing routine (22).
G16H 10/40 - TIC spécialement adaptées au maniement ou au traitement des données médicales ou de soins de santé relatives aux patients pour des données relatives aux analyses de laboratoire, p. ex. pour des analyses d’échantillon de patient
H04L 9/32 - Dispositions pour les communications secrètes ou protégéesProtocoles réseaux de sécurité comprenant des moyens pour vérifier l'identité ou l'autorisation d'un utilisateur du système
H04L 29/08 - Procédure de commande de la transmission, p.ex. procédure de commande du niveau de la liaison
G06F 21/64 - Protection de l’intégrité des données, p. ex. par sommes de contrôle, certificats ou signatures
The present invention relates to a method for conducting a bioprocess with a digital control unit (1) of a bioprocess arrangement (2), wherein the digital control unit (1) comprises a local data storage (4) and a local processor unit (5), wherein the digital control unit (1) comprises a bioprocess interface (6) for sending and receiving bioprocess control data, wherein bioprocess data (16) are generated by the digital control unit (1), wherein a bioprocess control routine (19) is executed by the local processor unit (5) to control the bioprocess, wherein in the bioprocess control routine (19), the bioprocess data (16) are generated by the digital control unit (1) from actuator data (8) and/or sensor data (12) and/or user control command data (18). It is proposed that a signing routine (24) is initiated by the local processor unit (5) in the data safety routine (21) to be executed by an external signing unit (s).
H04L 9/32 - Dispositions pour les communications secrètes ou protégéesProtocoles réseaux de sécurité comprenant des moyens pour vérifier l'identité ou l'autorisation d'un utilisateur du système
G05B 19/042 - Commande à programme autre que la commande numérique, c.-à-d. dans des automatismes à séquence ou dans des automates à logique utilisant des processeurs numériques
76.
BIOREACTOR SYSTEMS AND METHOD FOR OPERATING A BIOPROCESS
A bioreactor system (1) for receiving a disposable bioreactor bag (100) comprises a receiving container (10) having a container wall (11) which defines a receiving space (12) in which the disposable bioreactor bag (100) is received in an operating state of the bioreactor system (1). A stirring system (14) projects at least partially into the receiving space (12) and is designed and configured to stir a biomedium (101) present in the disposable bioreactor bag (100) in the operating state of the bioreactor system (1). At least one baffle (30; 40, 41, 42; 50; 60; 72; 73; 80; 81), which makes the receiving space (12) smaller and differs from the container wall (11), serves to reduce a laminar flow of the biomedium (101). A temperature control medium flows through at least part of the at least one baffle (30; 40, 41, 42; 50; 60; 72; 73; 80; 81), said temperature control medium controlling the temperature of the baffle (30; 40, 41, 42; 50; 60; 72; 73; 80; 81).
A safety device for a single-use mixing or storage system (10), especially for use in a biopharmaceutical process, comprises a flexible bag (12) made from a film material and a support structure (14) for receiving and supporting the bag (12) in several directions. The support structure (14) allows an expansion of the bag (12) in an expansion direction. The safety device further comprises a detection unit (20) adapted to detect an expansion of the bag (12) in the expansion direction, and a control unit (28) connected to the detection unit (20) and adapted to initiate a safety measure in case the expansion of the bag (12) in the expansion direction exceeds a given threshold.
B65B 3/00 - Emballage de matériaux plastiques, de semi-liquides, de liquides ou de liquides et solides mélangés, dans des réceptacles ou récipients individuels, p. ex. dans des sacs ou sachets, boîtes, cartons, bidons ou pots
B65B 3/26 - Dispositifs ou procédés pour régler la quantité de matériau fourni ou chargé
B65B 57/00 - Dispositifs de commande automatique, de vérification, d'alarme ou de sécurité
B65B 57/14 - Dispositifs de commande automatique, de vérification, d'alarme ou de sécurité sensibles à l'absence, à la présence, à l'alimentation anormale ou au mauvais positionnement des objets ou matériaux à emballer et dont le fonctionnement commande ou arrête l'alimentation des objets ou matériaux à emballer
B65B 57/18 - Dispositifs de commande automatique, de vérification, d'alarme ou de sécurité déclenchant des signaux d'alarme acoustiques ou optiques
F25D 19/00 - Disposition ou montage des groupes frigorifiques dans les dispositifs
F25D 29/00 - Disposition ou montage de l'appareillage de commande ou de sécurité
G01K 11/06 - Mesure de la température basée sur les variations physiques ou chimiques, n'entrant pas dans les groupes , , ou utilisant la fusion, la congélation ou le ramollissement
The invention relates to a valve block (10) for a one-time use in a bio process, comprising multiple valve units (12). The valve block (10) has a single-piece block body (14) with a main channel (16), at least one auxiliary channel (18) per valve unit (12), a valve seat (22) between the auxiliary channel (18) and the main channel (16), a closure part (24) with a gripping section (32), and an actuator (36) that is coupled to the gripping section (32) of the closure part (24) and can move the closure part (24) out of a first switch position of the valve unit (12), in which the closure part (24) is pressed against the valve seat (22) and a fluidic connection between the auxiliary channel (18) and the main channel (16) is blocked, and into a second switch position of the valve unit (12), in which the closure part (24) is lifted from the valve seat (22) and the fluid connection between the auxiliary channel (18) and the main channel (16) is released. The gripping section (32) is arranged such that the gripping section is sealed off from the main channel (16) as well as from the auxiliary channel (18) in the two switch positions of the valve unit (12).
F16K 27/02 - Structures des logementsMatériaux utilisés à cet effet des soupapes de levage
F16K 27/00 - Structures des logementsMatériaux utilisés à cet effet
F16K 11/22 - Soupapes ou clapets à voies multiples, p. ex. clapets mélangeursRaccords de tuyauteries comportant de tels clapets ou soupapesAménagement d'obturateurs et de voies d'écoulement spécialement conçu pour mélanger les fluides dont plusieurs éléments de fermeture ne se déplacent pas comme un tout actionnés par des organes de commande distincts chacun étant propre à une soupape, p. ex. conjugués pour former clapet à voies multiples
- 24 - Abstract A device assembly (10) for producing bioconjugates, in particular antibody-drug conjugates, comprises a conjugation unit for performing a bioconjugation reaction in a medium, a first filtration unit for separating precipitates and/or agglomerates, and a second filtration unit for performing an ultrafiltration and/or a diafiltration 5 process. The first filtration unit is arranged in a flow path between the conjugation unit and the second filtration unit. The device assembly (10) further comprises a single control unit (28) for controlling the transfer of medium from the conjugation unit through the first filtration unit to the second filtration unit and for controlling the ultrafiltration and/or diafiltration process. 10 Fig. 2
The invention is directed to an automated centrifuge setup of a bioprocessing installation for the separation of a cell broth by centrifugation, wherein, for the centrifugation, the centrifuge setup comprises a centrifuge (1), wherein the centrifuge (1) comprises at least one centrifuge chamber (2.1) with a chamber inlet (3) and a chamber outlet (4), wherein the centrifuge setup comprises a liquid pumping arrangement (5) and a liquid network (6) with a number of liquid lines (7) communicating with the liquid pumping arrangement (5). It is proposed, that the centrifuge setup comprises a sensor arrangement (11) with at least one biomass sensor arrangement (12.1), which biomass sensor arrangement (12.1) is assigned to a liquid line (7) of the liquid network (6), that the process control (10) calculates an occurrence level, preferably a concentration, of biomass in the respective liquid line (7) based on the sensor signals of the biomass sensor arrangement (12.1) and that the process control (10) controls the valve arrangement (8) and/or the liquid pumping arrangement (5) during the loading cycle and/or the washing cycle and/or the discharging cycle based on the sensor signals of the sensor arrangement (11).
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
81.
CLARIFICATION SETUP OF A BIOPROCESSING INSTALLATION
The invention is directed to a clarification setup of a bioprocessing installation for the clarification of a cell broth by centrifugation and subsequent filtration, wherein, for the centrifugation, the clarification setup comprises a centrifuge (1), wherein the centrifuge (1) comprises at least one centrifuge chamber (2) with a chamber inlet (3) and a chamber outlet (4), wherein the clarification setup comprises a liquid pumping arrangement (5) assigned to the centrifuge (1) and a liquid network (6) with a number of liquid lines (7) communicating with the liquid pumping arrangement (5), wherein the clarification setup comprises a process control (8) for controlling at least the centrifuge (1) and the liquid pumping arrangement (5). It is proposed that for filtration, the clarification setup comprises a filter arrangement (9), that the liquid network (6) provides an outlet supernatant line (10) for a liquid connection between the chamber outlet (4) and the filter arrangement (9), which is at least temporarily, preferably permanently, liquid-tight, such that due to this liquid-tight condition of the outlet supernatant line (10) the liquid pumping arrangement (5) as such may drive the supernatant from the chamber outlet (4) to the filter arrangement (9) via the outlet supernatant line (10).
A sparging device (10), especially for use in a bioprocess, comprises a medium chamber (20) and at least one gas chamber (24). The gas chamber (24) at least partially surrounds the medium chamber (20), or the medium chamber (20) at least partially surrounds the gas chamber (24). The medium (20) and the gas chamber (24) are separated from each other by a wall (22). The wall (22) has a plurality of through-holes (32) or is composed of a porous material, such as a membrane or a porous ceramic. The parging device (10) further comprises at least one gas inlet port (28) opening into the gas chamber (24) for inflow of gas.
INSTITUT FÜR LASERTECHNOLOGIE IN DER MEDIZIN UND MESSTECHNIK (STIFTUNG BÜRGERLICHES RECHT) (Allemagne)
Inventeur(s)
Nothelfer, Steffen
Kienle, Alwin
Foschum, Florian
Hoehse, Marek
Abrégé
The present invention relates to a device (100) and method for determining a viability and/or a cell count of biological cells in a cell suspension culture by means of collimated transmission. The device (100) comprises: - an illumination source (1) for generating an electromagnetic illumination beam; - beam manipulation means for collimating the illumination beam; and - a detection unit (13) for detecting an electromagnetic transmission beam being a portion of the collimated illumination beam which has been transmitted through a sample (6) of the cell suspension culture.
The invention relates to an aeration device for a bioprocessing installation (1), in particular a bioreactor (2), comprising a housing (9), wherein the housing (9) comprises one or more aeration channels (10a, 10b) in its interior, wherein the housing (9) further comprises one or more gas inlet ports (11), via each of which a gas can be introduced into at least one aeration channel (10a, 10b) of the housing (9), and wherein the housing (9) further comprises a plurality of gas outlet ports (12a, 12b), via each of which the gas can be discharged from the respective aeration channel (10a, 10b) to the outside of the aeration device (8). It is proposed that the aeration device (8) is configurable with respect to a pre- determined discharge of gas via the gas outlet ports (12a, 12b).
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
C12M 1/34 - Mesure ou test par des moyens de mesure ou de détection des conditions du milieu, p. ex. par des compteurs de colonies
85.
FILTRATION UNIT, METHOD FOR PRODUCING SAME, METHOD FOR DETECTING MICROORGANISMS AND USE OF THE FILTRATION UNIT
The present invention relates to a filtration unit with a filtration membrane, nutritive cardboard disc and, if necessary, a support structure, wherein the nutritive cardboard disc and/or the support structure comprises a solid, water-soluble nutrient medium and a water-soluble and/or water-swellable polymer, a method for producing the filtration unit, a method for detecting microorganisms in a fluid, wherein the filtration unit is used, and the use of the filtration unit for detecting microorganisms in a fluid.
The present invention relates to fluid processing system comprising a fluid processing unit and a tubing arrangement providing fluid flow to and from said fluid processing unit, wherein said tubing arrangement comprises one or more flow cells. Said fluid processing unit is selected from a unit comprising a single use tangential flow filtration mobile skid and a unit comprising a device for chromatographic separation. Each one of said flow cells comprises a body having an inlet and an outlet and a fluid flow channel extending from the inlet to the outlet of the body, said body further comprising a receptacle comprising a chamber forming a part of the fluid flow channel of the body, said chamber comprising a first opening for connecting a functional element to the flow cell such that the functional element is in contact with or exposed to a fluid flow passing through the fluid flow channel. The flow cells further comprise a functional element, a first tubular connector arranged adjacent to the inlet of the body, a second tubular connector arranged adjacent to the outlet of the body. A fluid flow path of the flow cell extends from the first tubular connector through the inlet of the body, the body and its receptacle to the outlet of the body to the second tubular connector.
B01L 3/00 - Récipients ou ustensiles pour laboratoires, p. ex. verrerie de laboratoireCompte-gouttes
G01N 21/85 - Analyse des fluides ou solides granulés en mouvement
G01N 27/06 - Recherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en recherchant l'impédance en recherchant la résistance d'un liquide
Connecting clamp for the mechanical connection of two bioprocess system components (2, 3) axially along a geometrical connecting axis (4), wherein the connecting clamp (1) has a locking body (5) which, in the definitively assembled state, runs radially around the geometrical connecting axis (4) and at least one of the bioprocess system components (2, 3). It is proposed that the connecting clamp (1) should have at least one clamping block (6), which interacts with the locking body (5) and is intended for the clamping connection of the bioprocess system components (2, 3), that the clamping block (6) should be movable, by means of a locking movement, out of an initial state, in which the clamping block (6) releases the bioprocess system components (2, 3), into a stable locking state, in which the clamping block (6) connects the bioprocess system components (2, 3) axially with clamping action, as a result of which the connecting clamp (1) and the bioprocess system components (2, 3) assume the definitively assembled state, and that the locking movement should comprise a movement of the locking body (5) in the axial direction relative to the bioprocess system components (2, 3), this movement causing the clamping block (6) to move out of the initial state into the locking state along with a movement component in the radial direction of the geometrical connecting axis (4).
F16L 37/12 - Accouplements du type à action rapide dans lesquels l'assemblage entre les extrémités s'aboutant ou se chevauchant est maintenu par des organes de blocage utilisant des crochets, cliquet, ou autres organes de blocage mobiles ou que l'on peut insérer
F16L 37/138 - Accouplements du type à action rapide dans lesquels l'assemblage entre les extrémités s'aboutant ou se chevauchant est maintenu par des organes de blocage utilisant des crochets, cliquet, ou autres organes de blocage mobiles ou que l'on peut insérer utilisant un manchon mobile axialement
88.
OPEN-LOOP/CLOSED-LOOP PROCESS CONTROL ON THE BASIS OF A SPECTROSCOPIC DETERMINATION OF UNDETERMINED SUBSTANCE CONCENTRATIONS
abababababb) in order to determine a prediction value for the undetermined concentration; and open-loop and/or closed-loop control (108) of the process (3) with respect to at least one parameter on the basis of the prediction value for the undetermined concentration.
G01N 21/31 - CouleurPropriétés spectrales, c.-à-d. comparaison de l'effet du matériau sur la lumière pour plusieurs longueurs d'ondes ou plusieurs bandes de longueurs d'ondes différentes en recherchant l'effet relatif du matériau pour les longueurs d'ondes caractéristiques d'éléments ou de molécules spécifiques, p. ex. spectrométrie d'absorption atomique
G01N 21/84 - Systèmes spécialement adaptés à des applications particulières
G01N 21/85 - Analyse des fluides ou solides granulés en mouvement
89.
FLOW CELL ASSEMBLY AND SPECTROSCOPY DEVICE ASSEMBLY FOR USE IN A BIOPROCESS
A flow cell assembly (10) for use in a bioprocess comprises a housing (12) and a glass body (14). The housing (12) includes an inlet tube connector (16) and an outlet tube connector (18). The housing (12) further includes a holding structure (20) for immovably holding the glass body (14). The glass body (14) is a universal single-piece glass body (14), preferably made of quartz glass, surrounding a measurement channel (26). The measurement channel (26) has an inlet end (28) and an outlet end (30) defining a medium flow direction. The measurement channel (26) has a defined dimension along an optical measurement axis (M) perpendicular to the medium flow direction. The inlet end (28) of the measurement channel (26) is in fluid communication with the inlet tube connector (16) of the housing (12). The outlet end (30) of the measurement channel (26) is in fluid communication with the outlet tube connector (18) of the housing (12). The housing (12) or the glass body (14) includes an aligning structure (22) for aligning a probe head (36). The housing (12) or the glass body (14) includes a fixing structure (24) for immovably fixing the aligned probe head (36) relative to the glass body (14).
2323ABAB23AB233) to at least one monitoring unit (14) for monitoring, open-loop and/or closed-loop control of foam formation (9) in the bioreactor plant (50) on the basis of said data.
The invention relates to a bioprocessing installation, in particular biopharmaceutical installation, comprising a reservoir tank (1), one or more fluid lines (4), one or more receiving containers (2) and an electronic control unit (8), wherein at least one fluid line (4) fluidically connects the reservoir tank (1 ) to at least one receiving container (2), wherein a liquid biological medium can be transferred, in particular pumped, from the reservoir tank (1) through the at least one fluid line (4) into the at least one receiving container (2). It is proposed that the bioprocessing installation comprises a sensor arrangement (9) with at least one gas bubble sensor (10), which sensor arrangement (9) is configured to detect one or more gas bubbles or foam or separated phases in the liquid biological medium by means of a gas bubble sensor (10) and to generate one or more corresponding sensor signals, and the electronic control unit (8) is configured to monitor the transfer of the liquid biological medium from the reservoir tank (1) in the direction of the at least one receiving container (2) based on the sensor signals generated by the sensor arrangement (9).
C12M 1/36 - Appareillage pour l'enzymologie ou la microbiologie comportant une commande sensible au temps ou aux conditions du milieu, p. ex. fermenteurs commandés automatiquement
A61J 3/00 - Dispositifs ou procédés spécialement conçus pour donner à des produits pharmaceutiques une forme physique déterminée ou une forme propre à leur administration
B65B 3/28 - Dispositifs ou procédés pour régler la quantité de matériau fourni ou chargé par pesage
B65B 57/10 - Dispositifs de commande automatique, de vérification, d'alarme ou de sécurité sensibles à l'absence, à la présence, à l'alimentation anormale ou au mauvais positionnement des objets ou matériaux à emballer
92.
SINGLE-USE DEVICE FOR THE SEPARATION OR FILTERING OF A LARGE VOLUME OF A MIXTURE OF SUBSTANCES
The invention relates to a single-use device (10) for the separation or filtering of a large volume of a mixture of substances, comprising a plurality of membrane chromatography modules (12), which are securely attached in a predefined grid formation. The single-use device (10) also comprises a piping system for linking the membrane chromatography modules (12) and for connecting the membrane chromatography modules (12) to one another. The membrane chromatography modules (12), in particular in terms of the membrane adsorber type, construction type and/or construction size, and/or the lines of the piping system are/can be pre-configured for a desired process. A cover unit (56) and/or a base unit (58) can be attached to the upper side and/or underside of a plurality of membrane chromatography modules (12), which holds the membrane chromatography modules (12) in position in a predefined grid formation. At least one part of the piping system of the single-use device (10) is formed in the cover unit (56) and/or in the base unit (58), with connecting lines between the membrane chromatography modules (12). In a method for separating or filtering a large volume of a mixture of substances using a single-use device (10) of this type with multiple automated valves (44) and sensors (48, 50, 52, 56), which are connected to a control unit, the automated valves (44) are controlled based on an evaluation of the parameters measured by the sensors (48, 50, 52, 56).
B01D 29/54 - Filtres à éléments filtrants stationnaires pendant la filtration, p. ex. filtres à aspiration ou à pression, non couverts par les groupes Leurs éléments filtrants à plusieurs éléments filtrants caractérisés par leur agencement relatif montés en parallèle disposés de façon concentrique ou coaxiale
B01D 15/18 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives aux différents types d'écoulement
B01D 15/22 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives à la structure de la colonne
B01D 29/56 - Filtres à éléments filtrants stationnaires pendant la filtration, p. ex. filtres à aspiration ou à pression, non couverts par les groupes Leurs éléments filtrants à plusieurs éléments filtrants caractérisés par leur agencement relatif montés en série
B01D 15/12 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives à la préparation de l'alimentation
93.
FILTRATION MODULE AND ASSEMBLY FOR FILTERING A PROCESS MEDIUM IN A BIOPROCESS AND METHOD OF SAMPLING DURING A BIOPROCESS
A filtration module (20) for filtering a process medium in a bioprocess, in particular in a biopharmaceutical process comprises a process flow path for a process medium, a filter membrane (20) coupled to the process flow path, and a sampling membrane (18) coupled both to the process flow path and to a sampling flow path (16) for extracting a sample from the process medium. The sampling flow path (16) guides the extracted sample to a sampling outlet of the filtration module (20) or to an analyzer integrated into the filtration module (20). A filtration assembly comprises such a filtration module and an analyzer coupled to the sampling outlet of the filtration module (20). A method of sampling during a bioprocess comprises the following steps: providing such a filtration module (20); urging a process medium through the process flow path; filtering the process medium by using the filter membrane (20) coupled to the process flow path; extracting a sample from the process medium by using the sampling membrane (18) coupled to both the process flow path and the sampling flow path (16); and guiding the extracted sample to a sampling outlet of the filtration module (20) or to an analyzer integrated into the filtration module (20). A computer program comprises instructions to effect at least one of the following: cause the means for urging the transport medium through the sampling flow path (16) of the filtration assembly to control the flow of the transport medium; control the analyzer of the filtration module (20) or the analyzer of the filtration assembly, especially providing settings and inputs to the analyzer; cause a process control unit of the filtration assembly to evaluate analysis data provided by the analyzer of the filtration module or the analyzer of the filtration assembly, and to adjust or control the bioprocess based on the evaluation.
The present invention relates to a method of changing culture medium of a suspension culture, the suspension culture comprising cells suspended in the culture medium, the method comprising: (i) transferring a fraction of the suspension culture into a container, wherein the container comprises at least one opening at the bottom; (ii) allowing the cells comprised in the fraction of the suspension to settle at the at least one opening at the bottom of the container by gravitation, thereby forming a supernatant; (iii) dispensing the cells settled at the bottom of the container (back) into the suspension culture; (iv) discarding the supernatant.
The invention relates to a modular processing system (100) for biopharmaceutical and/or chemical processes, comprising: at least one processing unit (10); at least one adapter plate (200), which can be directly or indirectly fluidically connected to the processing unit (10), wherein the adapter plate (200) has at least one adapter channel (214), through which at least one fluid flow (14) can flow, which flows to the processing unit (10), wherein the adapter plate (200) also has at least one deflection element and/or a pump (258) and/or at least one valve; and an external control device (400). The adapter plate (200) is designed in such a way that the fluid flow (14) to the processing unit (10) can be at least partially deflected by the at least one deflection element in the adapter channel (214), and/or the fluid flow (14), preferably the pressure thereof, can be controlled by the at least one valve and/or the pump (258) in the adapter channel (214). A respective at least one sensor (36, 228) is embedded in the processing unit (10) and/or in the adapter plate (200), in order to detect at least one property of the fluid flow (14) in the processing unit (10) or the adapter plate (200). The external control device (400) can be coupled to the at least `one sensor (36, 228) in such a way that measurement data of at least one sensor (36, 228) can be read out, and the fluid flow (14) in the processing unit (10) and/or the adapter plate (200) can be centrally controlled based on the read-out measurement data. The invention also relates to a method for centrally controlling a modular processing system (100) for biopharmaceutical and/or chemical processes.
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
C12M 3/00 - Appareillage pour la culture de tissus, de cellules humaines, animales ou végétales, ou de virus
C12M 1/02 - Appareillage pour l'enzymologie ou la microbiologie avec des moyens d'agitationAppareillage pour l'enzymologie ou la microbiologie avec des moyens d'échange de chaleur
C12M 1/34 - Mesure ou test par des moyens de mesure ou de détection des conditions du milieu, p. ex. par des compteurs de colonies
96.
IMPROVED DIATOMACEOUS EARTH COMPOSITION CONTAINING SALT WATER
The present invention relates to an improved diatomaceous earth composition containing salt water. The diatomaceous earth composition according to the present invention comprises an agglomerated mixture of calcined diatomaceous earth particles, water and at least one inorganic salt, wherein the mass ratio of the calcined diatomaceous earth particles and water is in the range of 1:1.0 to 1:2.0, and wherein the content of the at least one inorganic salt is equal to or more than 0.25 parts by mass based on 100 parts by mass of water. In a further aspect, the present invention relates to a method for producing the diatomaceous earth composition according to the present invention. In another aspect, the present invention relates to the use of the diatomaceous earth composition according to the present invention as an agent for precoat filtration or dynamic body feed filtration in biopharmaceutical applications.
B01J 20/04 - Compositions absorbantes ou adsorbantes solides ou compositions facilitant la filtrationAbsorbants ou adsorbants pour la chromatographieProcédés pour leur préparation, régénération ou réactivation contenant une substance inorganique contenant des composés des métaux alcalins, des métaux alcalino-terreux ou du magnésium
B01J 20/30 - Procédés de préparation, de régénération ou de réactivation
C12N 1/02 - Séparation des micro-organismes de leurs milieux de culture
A61L 2/08 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des phénomènes physiques des radiations
B01D 37/02 - Revêtement préalable des éléments filtrants ou de la substance filtranteAddition d'adjuvants de filtration au liquide à filtrer
97.
METHOD FOR DEGASSING A CROSS-FLOW DIAFILTRATION UNIT, CROSS-FLOW DIAFILTRATION METHOD AND CROSS-FLOW DIAFILTRATION UNIT
The present invention relates to a method for degassing a cross-flow diafiltration unit, to a cross-flow diafiltration method and to a cross-flow diafiltration unit.
System for an automated production of high cell density seed culture, HCDC, preparations, for cryo-preservation comprising a cell expansion device for growing a HCDC in a medium inside a device volume of the cell expansion device, at least one sensor for collecting data by at least temporally monitoring at least one parameter being indicative of the physiological state of the HCDC; and a control unit for processing the collected data to determine whether at least one predetermined criterion is fulfilled by the monitored parameter to control, based on whether the at least one predetermined criterion is fulfilled by the monitored parameter, at least a partial exchange of the medium by a cryo-protective agent, CPA,
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
99.
CROSSFLOW FILTRATION METHOD, METHOD FOR OBTAINING AT LEAST ONE CROSSFLOW FILTRATION PARAMETER AND SYSTEM FOR OBTAINING AT LEAST ONE CROSSFLOW FILTRATION PARAMETER
The present invention relates to a crossflow filtration method, a method for obtaining at least one crossflow filtration parameter and a system for obtaining at least one crossflow filtration parameter.
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