The present disclosure relates to methods for producing lentiviral vector-producing cells. Specifically the methods utilize two plasmids, rather than four, to provide the required packaging elements and transfer vector to a cell, allowing for the production of a large number of lentiviral producer cells, including suspension-based cells, and the production of high amounts of lentivirus. These methods allow for the production of cells that can be later induced to produce lentivirus, and can be tailored to include a specific gene of interest.
The present disclosure provides novel transcription control elements comprising an enhancer element operably linked to a mammalian endogenous promoter sequence and optionally a mammalian intron sequence, resulting in strong fusion promoters for constitutive high-level recombinant gene transcription in mammalian cells including CHO cells or CHO-derived cells.
The present disclosure provides methods for assessing and optimizing cellular quality of a cell-based therapy that is being produced in an automated cell engineering system. The methods suitably include monitoring molecular characteristics of the cells before, during, and after the automated process to provide feedback to the process parameters. In embodiments, the cells being produced are Chimeric Antigen Receptor (CAR) T-cells.
The present disclosure provides an automated method of producing viral vectors, utilizing engineered viral vector-producing cell lines within a fully-enclosed cell engineering system. Exemplary viral vectors that can be produced include lentivirus vectors, adeno-associated virus vectors, baculovirus vectors and retrovirus vectors.
The present disclosure provides systems, devices, and methods for electroporating at least one cell in a plurality of cells. A cartridge divided into a plurality of separate chambers is provided, where each chamber of the plurality of separate chambers is configured to hold a media comprising the at least one cell. Each chamber of the plurality of separate chambers is fluidly connected via a fluid exchange path, and are functionally separated by constrictions disposed within the fluid exchange path. Each chamber of the plurality of separate chambers includes electrodes for applying a pulsed electrical field to the at least one cell to achieve electroporation and transfection of the cell with nucleic acids. The constrictions disposed between each chamber prevents electric field interference between adjacent chambers during the electroporation procedures.
09 - Scientific and electric apparatus and instruments
42 - Scientific, technological and industrial services, research and design
Goods & Services
Computer software for the management, monitoring, data
storage, and support of equipment for manufacturing
autologous cell therapies. Software as a service for the management, monitoring, data
storage, and support of equipment for manufacturing
autologous cell therapies.
The present disclosure relates to multistep chromatographic methods for preparing extracellular vesicles (EVs). The methods were demonstrated to be effective in preparing high-quality EVs in a large scale. The methods enable preparation of EVs for therapeutic and diagnostic applications, and isolation and/or sub-fractionation of EVs with desired properties for specific use.
B01D 15/08 - Selective adsorption, e.g. chromatography
B01D 15/16 - Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
B01D 15/20 - Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the sorbent material
09 - Scientific and electric apparatus and instruments
Goods & Services
Automated cell imaging and picking system for screening, selection, and isolation of single cells; cell culture apparatus for laboratory use, either with or without the assistance of a cell culture digital imaging system
17.
Methods and constructs for production of lentiviral vector
The present disclosure relates to methods for producing lentiviral vector-producing cells. Specifically the methods utilize two plasmids, rather than four, to provide the required packaging elements and transfer vector to a cell, allowing for the production of a large number of lentiviral producer cells, including suspension-based cells, and the production of high amounts of lentivirus. These methods allow for the production of cells that can be later induced to produce lentivirus, and can be tailored to include a specific gene of interest.
The present disclosure provides methods of producing extracellular vesicles and methods of increasing extracellular vesicle production from producer cells, which exhibit a reduced gene and/or protein function in a cholesterol biosynthetic pathway, wherein the producer cells are contacted with cholesterol.
A61K 31/40 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
A61K 31/575 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
09 - Scientific and electric apparatus and instruments
42 - Scientific, technological and industrial services, research and design
Goods & Services
(1) Computer software for the management, monitoring, data storage, and support of equipment for manufacturing autologous cell therapies. (1) Software as a service for the management, monitoring, data storage, and support of equipment for manufacturing autologous cell therapies.
09 - Scientific and electric apparatus and instruments
42 - Scientific, technological and industrial services, research and design
Goods & Services
Downloadable computer software for the management, monitoring, data storage, and support of equipment for manufacturing autologous cell therapies Software as a service (SAAS) featuring software for the management, monitoring, data storage, and support of equipment for manufacturing autologous cell therapies
21.
METHODS OF USING EXTRACELLULAR VESICLE-ASO TARGETING STAT6
A closed, automated and scalable stirred tank bioreactor platform, capable of sustaining high fold expansion of hPSCs is provided. hPSCs are expanded in a controlled bioreactor using perfused xeno-free media. Cell harvest and concentration are performed in closed steps. The hPSCs can be cryopreserved to generate a bank of cells or further processed as needed. Cryopreserved cells can be thawed into a 2D tissue culture platform or a 3D bioreactor to initiate a new expansion phase or be differentiated to the clinically relevant cell type. The expanded hPSCs express hPSC-specific markers, have a normal karyotype and the ability to differentiate to the cells of the three germ layers. This end-to-end platform allows large expansion of high quality hPSCs that can support the required cell demand for various clinical indications.
e.g.,e.g., exosomes) comprising a biologically active molecule covalently linked to the extracellular vesicle via a cleavable linker and an anchoring moiety. The extracellular vesicles can be useful as an agent for the prophylaxis or treatment of cancer or other diseases. Also provided herein are methods for producing the extracellular vesicles and methods for using the extracellular vesicles to treat diseases or disorders.
A61K 47/69 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
A61K 47/55 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound the modifying agent being also a pharmacologically or therapeutically active agent, i.e. the entire conjugate being a codrug, i.e. a dimer, oligomer or polymer of pharmacologically or therapeutically active compounds
A61K 47/65 - Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
A61K 31/7088 - Compounds having three or more nucleosides or nucleotides
24.
EXTRACELLULAR VESICLE COMPRISING A BIOLOGICALLY ACTIVE MOLECULE AND A DUAL CLEAVABLE LINKER
e.g.,e.g., exosomes) comprising a biologically active molecule covalently linked to the extracellular vesicle via a dual cleavable linker and an anchoring moiety. The extracellular vesicles can be useful as an agent for the prophylaxis or treatment of cancer or other diseases. Also provided herein are methods for producing the extracellular vesicles and methods for using the extracellular vesicles to treat diseases or disorders.
A61K 47/69 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
A61K 47/55 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound the modifying agent being also a pharmacologically or therapeutically active agent, i.e. the entire conjugate being a codrug, i.e. a dimer, oligomer or polymer of pharmacologically or therapeutically active compounds
A61K 47/65 - Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
A61K 31/7088 - Compounds having three or more nucleosides or nucleotides
25.
EXTRACELLULAR VESICLE COMPRISING A BIOLOGICALLY ACTIVE MOLECULE AND A CELL PENETRATNG PEPTIDE CLEAVABLE LINKER
e.g.,e.g., exosomes) comprising a biologically active molecule covalently linked to the extracellular vesicle via a cleavable linker comprising a cell penetrating peptide and an anchoring moiety. The extracellular vesicles can be useful as an agent for the prophylaxis or treatment of cancer or other diseases. Also provided herein are methods for producing the extracellular vesicles and methods for using the extracellular vesicles to treat diseases or disorders.
A61K 47/69 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
A61K 47/55 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound the modifying agent being also a pharmacologically or therapeutically active agent, i.e. the entire conjugate being a codrug, i.e. a dimer, oligomer or polymer of pharmacologically or therapeutically active compounds
A61K 47/65 - Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
A61K 31/7088 - Compounds having three or more nucleosides or nucleotides
The present disclosure provides an automated method of producing genetically modified immune cells, including chimeric antigen receptor T (CAR T) cells, utilizing a fully-enclosed cell engineering system.
e.g.CEBP/β CEBP/β transcript. Also provided herein are methods for producing the exosomes and methods for using the exosomes to treat and/or prevent diseases or disorders.
C12N 15/113 - Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides
C12N 15/88 - Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation using microencapsulation, e.g. using liposome vesicle
The present disclosure provides an automated method of producing viral vectors, utilizing engineered viral vector-producing cell lines within a fully-enclosed cell engineering system. Exemplary viral vectors that can be produced include lentivirus vectors, adeno-associated virus vectors, baculovirus vectors and retrovirus vectors.
The present disclosure provides cell culture chambers for use in automated cell engineering systems, and in particular, cell culture chambers that provide increased cell yield. A cell culture chamber may include a first body forming a first portion of the cell culture chamber. A cell culture chamber may include a second body forming a second portion of the cell culture chamber, the first body and the second body configured to couple together, forming an enclosed volume, wherein a first non-porous, gas-permeable material is disposed on the first body; and wherein the first non-porous, gas-permeable material and the first body are formed together. A second non-porous, gas-permeable material may be disposed on the second body, and the second non-porous, gas-permeable material and the second body may be formed together. The cell culture chamber may further include at least one bubble trap integrally formed with the first body and/or the second body.
The present disclosure relates to a mammalian cell line for producing adeno-associated virus (AAV), suitably including nucleic acids encoding helper genes and AAV genes, under the control of derepressible promoters. The disclosure also relates to isolated nucleic acid molecules that encode such genes, as well as methods of using the mammalian cells for producing AAVs.
The present disclosure provides an automated method of producing genetically modified immune cells, including chimeric antigen receptor T (CAR T) cells, utilizing a fully-enclosed cell engineering system.
The present disclosure provides editable cell lines, including the use of gene editing proteins to produce the cell lines. The editable cell lines are able to express antibody constant regions that can serve as a platform for the antibody variable regions to produce customized antibody.
The present disclosure provides editable cell lines, including the use of gene editing proteins to produce the cell lines. The editable cell lines are able to express antibody constant regions that can serve as a platform for the antibody variable regions to produce customized antibody.
The present disclosure provides devices and associated methods for temperature monitoring and control in automated biological material engineering systems, including cell engineering systems. The devices and methods utilize measurement of internal temperatures in an automated system to map temperatures during the various processes carried out in the systems.
The present disclosure provides cassettes for use in automated cell engineering systems that include cell concentration filters for reducing fluid volume of a cell sample during or following automated processing. The disclosure also provides methods of concentrating a cell population, as well as automated cell engineering systems that can utilize the cassettes and carry out the methods.
The present disclosure provides methods for processing cell-derived vesicles in which the cell-derived vesicles are not purified, prior to contacting with a fluorescent staining dye or an antibody. By utilizing a centrifugal filter, excess staining dye or antibody can be readily removed prior to analysis of one or more characteristics of the cell-derived vesicles. The methods provide rapid and simple processing and analysis, while maintaining a high concentration of cell-derived vesicles.
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
G01N 33/537 - ImmunoassayBiospecific binding assayMaterials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody
37.
METHODS FOR NUCLEAR REPROGRAMMING USING SYNTHETIC TRANSCRIPTION FACTORS
The current disclosure provides methods for reprogramming mammalian somatic cells by regulating the expression of endogenous cellular genes. Cellular reprogramming of somatic cells can be induced by activating the transcription of embryonic stem cell-associated genes (e.g., oct3/4) and suppressing the transcription of somatic cell-specific and/or cell death-associated genes. The endogenous transcription machinery can be modulated using synthetic transcription factors (activators and suppressors), to allow for faster, and more efficient nuclear reprogramming under conditions amenable for clinical and commercial applications. The current disclosure further provides cells obtained from such methods, along with therapeutic methods for using such cells for the treatment of diseases amendable to stem cell therapy, as well as kits for such uses.
A61K 35/15 - Cells of the myeloid line, e.g. granulocytes, basophils, eosinophils, neutrophils, leucocytes, monocytes, macrophages or mast cellsMyeloid precursor cellsAntigen-presenting cells, e.g. dendritic cells
The present technology is generally related to storage structures for cell engineering systems. The storage structures allow for multiple automated cell engineering systems to be held via a single structure, and presented to a user when desired or needed for direct access to the cell engineering system, and then returned to a storage or working position. Many storage structures can be arranged together in a clinical or hospital setting, or other cell therapy engineering manufacturing environment.
C12N 5/02 - Propagation of single cells or cells in suspensionMaintenance thereofCulture media therefor
C12N 1/38 - Chemical stimulation of growth or activity by addition of chemical compounds which are not essential growth factorsStimulation of growth by removal of a chemical compound
C12N 5/0783 - T cellsNK cellsProgenitors of T or NK cells
A61K 35/17 - LymphocytesB-cellsT-cellsNatural killer cellsInterferon-activated or cytokine-activated lymphocytes
41.
METHODS FOR PROCESSING AND ANALYZING EXTRACELLULAR VESICLES
The present disclosure provides methods for processing extracellular vesicles in which the extracellular vesicles are not purified, prior to contacting with a fluorescent staining dye or an antibody. By utilizing a centrifugal filter, excess staining dye or antibody can be readily removed prior to analysis of one or more characteristics of the extracellular vesicles. The methods provide rapid and simple processing and analysis, while maintaining a high concentration of extracellular vesicles.
The present disclosure relates to methods for determining a viral titer of a biological sample, suitably from a mammalian cell sample. The methods include the use of mechanical disruption of the cells, followed by droplet digital polymerase chain reaction (ddPCR) to determine the viral titer. Methods of mechanical disruption suitably include the use of glass beads.
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving virus or bacteriophage
43.
Methods and constructs for transient production of lentiviral vector
The present disclosure relates to methods for producing lentiviral vectors using mammalian cells. Specifically, the methods utilize three plasmids, rather than four, to provide the required packaging elements and transfer vector to a cell, allowing for the production of a large number of lentiviral vectors in mammalian cells, including suspension-based cells. These methods allow for the production of lentiviral vectors that can be tailored to include a specific gene of interest.
A filter apparatus is disclosed for withdrawing a fluid medium from a bioreactor during the growth of a cell culture within the bioreactor. Also disclosed is a method for culturing cells in a bioreactor. The filter apparatus includes a hollow tubular member attached to a filter member. The filter member has a pore size and volume capable of withdrawing a fluid medium at a relatively high flow rate from the bioreactor. Without withdrawing biological cells from the bioreactor and without damaging or harming the cells. The filter apparatus of the present disclosure allows for many process improvements.
The present disclosure provides combinatorial fluid switches that allow for the selection of a single fluid flow-path, while controlling multiple flow-paths. The combinatorial fluid switches can be used in various biological systems and processes, included automated cell engineering systems.
C12M 3/06 - Tissue, human, animal or plant cell, or virus culture apparatus with filtration, ultrafiltration, inverse osmosis or dialysis means
C12M 1/00 - Apparatus for enzymology or microbiology
F16K 11/20 - Multiple-way valves, e.g. mixing valvesPipe fittings incorporating such valvesArrangement of valves and flow lines specially adapted for mixing fluid with two or more closure members not moving as a unit operated by separate actuating members
F16K 99/00 - Subject matter not provided for in other groups of this subclass
46.
CARTRIDGE WITH MIXING ZONE FOR ENDOTOXIN DETECTION
The present invention is directed to methods, compositions and devices useful for the detection and/or quantification of a microbial contaminant, including an endotoxin. In embodiments, cartridges are provided that suitably include dried compositions that are useful in absorbance-based assays and in combination with portable readers/devices.
The present disclosure provides an automated method of producing genetically modified immune cells, including chimeric antigen receptor T (CAR T) cells, utilizing a fully-enclosed cell engineering system.
The present disclosure provides an automated method of producing genetically modified immune cells, including chimeric antigen receptor T (CAR T) cells, utilizing a fully-enclosed cell engineering system.
The present disclosure provides an automated method of producing genetically modified immune cells, including chimeric antigen receptor T (CAR T) cells, utilizing a fully-enclosed cell engineering system.
The present invention is related to compositions comprising clarified limulus amebocyte lysate (LAL), wherein the LAL is substantially free of coagulogen and methods of making such compositions. The invention further relates to a method of detecting an endotoxin in a sample using a chromogenic assay, the method comprising: (a) contacting the sample with a reagent comprising clarified LAL and a chromogenic substrate; and (b) measuring a chromogenic effect resulting from a change in the chromogenic substrate in the presence of endotoxin in the sample, wherein the LAL is substantially free of coagulogen. The invention also relates to kits comprising clarified LAL substantially free of coagulogen, and methods of making such.
G01N 33/579 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving limulus lysate
C12Q 1/37 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase involving peptidase or proteinase
51.
TEMPERATURE CALIBRATION METHODS AND DEVICES FOR USE IN AUTOMATED BIOREACTORS
The present disclosure provides devices and associated methods for temperature monitoring and control in automated biological material engineering systems, including cell engineering systems. The devices and methods utilize measurement of internal temperatures in an automated system to map temperatures during the various processes carried out in the systems.
Devices and methods for sterile sampling from automated cell engineering systems are provided. Sterile sampling devices are configured to maintain sterility of a sample reservoir during intake and expulsion of fluids or other material to the sterile sampling devices. Methods provided herein employ sterile sampling devices to achieve the sterile withdrawal and sterile injection of materials and fluids to and from an automated cell engineering system.
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
A61M 3/00 - Medical syringes, e.g. enemataIrrigators
A61M 1/00 - Suction or pumping devices for medical purposesDevices for carrying-off, for treatment of, or for carrying-over, body-liquidsDrainage systems
53.
AUTOMATED DOWNSTREAM PROCESSING OF A BIOLOGIC PRODUCT
The present disclosure provides an automated downstream processing module for processing of a biologic product and methods of using said module. The downstream processing module can process a biologic product from any source, including an automated fully-enclosed upstream production module.
The present invention is related to a method of detecting an endotoxin in a sample using a chromogenic assay, the method comprising: (a) contacting the sample with a reagent comprising limulus amebocyte lysate (LAL) and a chromogenic substrate; and (b) measuring a chromogenic effect resulting from a change in the chromogenic substrate in the presence of endotoxin in the sample; wherein the LAL is substantially free of coagulogen. The method also relates to compositions and kits comprising LAL substantially free of coagulogen, and methods of making such.
G01N 33/579 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving limulus lysate
C12Q 1/37 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase involving peptidase or proteinase
01 - Chemical and biological materials for industrial, scientific and agricultural use
Goods & Services
Cell culture media and cell culture feeds being cell growth media to support production of recombinant proteins and monoclonal antibodies, for scientific research purposes
Provided are viral vector formulations comprising a globular protein such as an albumin. Also provided are viral vector formulations comprising a polysaccharide such as an hyaluronic acid. The provided viral vector formulations have increased stability and reduced viral vector aggregation.
The present disclosure provides a method of determining the concentration of a polysorbate, the method comprising providing a composition comprising a protein and the polysorbate, adding a second surfactant to the composition, wherein the concentration of the second surfactant in the composition is below the critical micelle concentration (CMC) of the second surfactant, and wherein the second surfactant has a CMC mass value higher than the polysorbate CMC mass value, precipitating the protein in the composition to form a precipitate and a supernatant, and determining the concentration of the polysorbate in the supernatant using a fluorescent micelle assay.
09 - Scientific and electric apparatus and instruments
10 - Medical apparatus and instruments
Goods & Services
Analytical apparatus and instruments for scientific or
non-medical use, namely, measurement appliances for
measuring rates of absorption, luminescence, fluorescence
and electronic scanning appliances, namely, microplate
readers, all the aforesaid products intended for laboratory
use and commercial use. Analytical apparatus and instruments for use in clinical
diagnostics and veterinary medicine, namely, measurement
appliances for measuring rates of absorption, luminescence,
fluorescence and electronic scanning appliances, namely,
medical and diagnostic microplate readers, all the aforesaid
products intended for laboratory use and commercial use.
09 - Scientific and electric apparatus and instruments
10 - Medical apparatus and instruments
Goods & Services
Analytical apparatus and instruments for scientific or non-medical use, namely, measurement appliances for measuring rates of absorption, luminescence, fluorescence and electronic scanning appliances, namely, microplate readers, all the aforesaid products intended for laboratory use and commercial use. Analytical apparatus and instruments for use in clinical diagnostics and veterinary medicine, namely, measurement appliances for measuring rates of absorption, luminescence, fluorescence and electronic scanning appliances, namely, medical and diagnostic microplate readers, all the aforesaid products intended for laboratory use and commercial use.
The present disclosure relates to methods for determining a viral titer of a biological sample, suitably from a mammalian cell sample. The methods include the use of mechanical disruption of the cells, followed by droplet digital polymerase chain reaction (ddPCR) to determine the viral titer. Methods of mechanical disruption suitably include the use of glass beads.
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving virus or bacteriophage
A filter apparatus is disclosed for withdrawing a fluid medium from a bioreactor during the growth of a cell culture within the bioreactor. Also disclosed is a method for culturing cells in a bioreactor. The filter apparatus includes a hollow tubular member attached to a filter member. The filter member has a pore size and volume capable of withdrawing a fluid medium at a relatively high flow rate from the bioreactor. Without withdrawing biological cells from the bioreactor and without damaging or harming the cells. The filter apparatus of the present disclosure allows for many process improvements.
09 - Scientific and electric apparatus and instruments
10 - Medical apparatus and instruments
Goods & Services
(1) Analytical apparatus and instruments for scientific or non-medical use, namely, spectrophotometers for measuring rates of absorption, luminescence, fluorescence and electronic scanning appliances, namely, microplate readers, all the aforesaid products intended for laboratory use and commercial use
(2) Analytical apparatus and instruments for use in clinical diagnostics and veterinary medicine, namely, spectrophotometers for measuring rates of absorption, luminescence, fluorescence and electronic scanning appliances, namely, medical and diagnostic microplate readers, all the aforesaid products intended for laboratory use and commercial use
09 - Scientific and electric apparatus and instruments
Goods & Services
Analytical apparatus and instruments for scientific or non-medical use, namely, measurement appliances for measuring rates of absorption, luminescence, fluorescence and electronic scanning appliances, namely, microplate readers, all the aforesaid products intended for laboratory use and commercial use; Medical and veterinary laboratory analytical apparatus and instruments, namely, measurement appliances for measuring rates of chemical absorption, luminescence, and fluorescence, and electronic scanning appliances in the nature of microplate readers, with the analytical data rendered by the foregoing for ultimate use in clinical diagnoses
The present disclosure provides an automated method of producing viral vectors, utilizing engineered viral vector-producing cell lines, or packaging cells, within a fully-enclosed cell engineering system. Exemplary viral vectors that can be produced include lentivirus vectors, adeno-associated virus vectors, baculovirus vectors and retrovirus vectors.
The present disclosure relates to methods for producing lentiviral vectors using mammalian cells. Specifically, the methods utilize three plasmids, rather than four, to provide the required packaging elements and transfer vector to a cell, allowing for the production of a large number of lentiviral vectors in mammalian cells, including suspension-based cells. These methods allow for the production of lentiviral vectors that can be tailored to include a specific gene of interest.
The present invention provides methods for producing allogeneic T-cells, including the use of an engineered nuclease under the control of a controllable promoter. By preparing T-cells with an inducible nuclease, large volumes of cells can be prepared, each of which contains the ability to individually produce the desired nuclease. These cells can then be modified as desired through the introduction of a gene of interest, or an undesired gene can be knocked-out. Also provided herein are allogeneic T-cells for use in various therapeutic applications.
The present disclosure provides a method of purifying polysaccharides from a cell lysate, comprising partially purifying the cell lysate comprising an impurity and a polysaccharide to obtain a clarified crude lysate; mixing the clarified crude lysate with a neutralization solution comprising a salt to form a neutralized lysate; mixing the neutralized lysate with a precipitation solution comprising cetyltrimethylammonium bromide to form a first supernatant and a first precipitate; and separating the first precipitate from the first supernatant, wherein the polysaccharide is located in the first supernatant. The present disclosure further provides a method of making a polysaccharide vaccine. Also provided are vaccines, delivery systems, compositions and polysaccharides made by the methods described herein.
A closed, automated and scalable stirred tank bioreactor platform, capable of sustaining high fold expansion of hPSCs is provided. hPSCs are expanded in a controlled bioreactor using perfused xeno-free media. Cell harvest and concentration are performed in closed steps. The hPSCs can be cryopreserved to generate a bank of cells or further processed as needed. Cryopreserved cells can be thawed into a 2D tissue culture platform or a 3D bioreactor to initiate a new expansion phase or be differentiated to the clinically relevant cell type. The expanded hPSCs express hPSC-specific markers, have a normal karyotype and the ability to differentiate to the cells of the three germ layers. This end-to-end platform allows large expansion of high quality hPSCs that can support the required cell demand for various clinical indications.
The present disclosure provides methods for assessing and optimizing cellular quality of a cell-based therapy that is being produced in an automated cell engineering system. The methods suitably include monitoring molecular characteristics of the cells before, during, and after the automated process to provide feedback to the process parameters. In embodiments, the cells being produced are Chimeric Antigen Receptor (CAR) T-cells.
The present disclosure provides methods for assessing and optimizing cellular quality of a cell-based therapy that is being produced in an automated cell engineering system. The methods suitably include monitoring molecular characteristics of the cells before, during, and after the automated process to provide feedback to the process parameters. In embodiments, the cells being produced are Chimeric Antigen Receptor (CAR) T-cells.
The present invention provides methods for producing allogeneic T-cells, including the use of an engineered nuclease under the control of a controllable promoter. By preparing T-cells with an inducible nuclease, large volumes of cells can be prepared, each of which contains the ability to individually produce the desired nuclease. These cells can then be modified as desired through the introduction of a gene of interest, or an undesired gene can be knocked-out. Also provided herein are allogeneic T-cells for use in various therapeutic applications.
The present disclosure provides cell culture chambers for use in automated cell engineering systems, and in particular, cell culture chambers that include improved cell-contacting surfaces. Improved cell-contacting surfaces can include a surface coating that promotes cell growth, adherence, differentiation, maintenance of phenotype, and/or improves transduction; a cell-contacting surface comprising a non-porous, gas-permeable material; as well as other modifications to the cell-contacting surfaces. Cassettes comprising the cell culture chambers are also provided.
The present disclosure provides cell culture chambers for use in automated cell engineering systems, and in particular, cell culture chambers that include improved cell-contacting surfaces. Improved cell-contacting surfaces can include a surface coating that promotes cell growth, adherence, differentiation, maintenance of phenotype, and/or improves transduction; a cell-contacting surface comprising a non-porous, gas-permeable material; as well as other modifications to the cell-contacting surfaces. Cassettes comprising the cell culture chambers are also provided.
The present disclosure provides compositions, methods, and kits for detecting lipolytic activity. In some embodiments, the composition comprises an aqueous assay sample and an organic solvent, wherein the organic solvent comprises 4-methylumbelliferyl oleate (4MuO). Also provided herein are methods for determining the stability of a protein preparation.
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase
C12Q 1/44 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase involving esterase
A61K 39/00 - Medicinal preparations containing antigens or antibodies
The present disclosure provides a method of producing a population of lyophilized cells, comprising: (a) freezing a composition comprising a population of cells, an aqueous component, a polyol, a sugar, and a polysaccharide; and (b) removing at least 90% of the aqueous component from the frozen composition to produce the population of lyophilized cells. On some embodiments, the disclosure provides a method of producing a population of reconstituted viable cells, comprising: (a) freezing a composition comprising a population of cells, an aqueous component, a polyol, a sugar, and a polysaccharide; (b) removing at least 90% of the aqueous component from the frozen composition to produce the population of lyophilized cells, and (c) resuspending the population of lyophilized cells in a reconstitution agent to form a reconstituted composition, wherein at least 1% of the cells are viable.
F26B 5/06 - Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
C12N 1/04 - Preserving or maintaining viable microorganisms
C12N 5/071 - Vertebrate cells or tissues, e.g. human cells or tissues
79.
Methods and constructs for production of lentiviral vector
The present disclosure relates to methods for producing lentiviral vector-producing cells. Specifically the methods utilize two plasmids, rather than four, to provide the required packaging elements and transfer vector to a cell, allowing for the production of a large number of lentiviral producer cells, including suspension-based cells, and the production of high amounts of lentivirus. These methods allow for the production of cells that can be later induced to produce lentivirus, and can be tailored to include a specific gene of interest.
The present disclosure relates to methods for producing lentiviral vector-producing cells. Specifically the methods utilize two plasmids, rather than four, to provide the required packaging elements and transfer vector to a cell, allowing for the production of a large number of lentiviral producer cells, including suspension-based cells, and the production of high amounts of lentivirus. These methods allow for the production of cells that can be later induced to produce lentivirus, and can be tailored to include a specific gene of interest.
The present invention is directed to methods, compositions and devices useful for the detection and/or quantification of a microbial contaminant, including an endotoxin. In embodiments, cartridges are provided that suitably include dried compositions that are useful in absorbance-based assays and in combination with portable readers/devices.
Systems and methods for process control of automated cell engineering systems are provided. Automated cell engineering systems provide automated cell processing functionality. Automated process control systems provide control, interconnectivity, monitoring, data archival, software updating, and other oversight functions for automated cell engineering systems. Further, central control process systems provide control, monitoring, data archival, software updating, and other oversight functions for automated process control systems.
C12M 1/36 - Apparatus for enzymology or microbiology including condition or time responsive control, e.g. automatically controlled fermentors
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
83.
Methods for nuclear reprogramming using synthetic transcription factors
The current disclosure provides methods for reprogramming mammalian somatic cells by regulating the expression of endogenous cellular genes. Cellular reprogramming of somatic cells can be induced by activating the transcription of embryonic stem cell-associated genes (e.g., oct3/4) and suppressing the transcription of somatic cell-specific and/or cell death-associated genes. The endogenous transcription machinery can be modulated using synthetic transcription factors (activators and suppressors), to allow for faster, and more efficient nuclear reprogramming under conditions amenable for clinical and commercial applications. The current disclosure further provides cells obtained from such methods, along with therapeutic methods for using such cells for the treatment of diseases amendable to stem cell therapy, as well as kits for such uses.
A61K 35/15 - Cells of the myeloid line, e.g. granulocytes, basophils, eosinophils, neutrophils, leucocytes, monocytes, macrophages or mast cellsMyeloid precursor cellsAntigen-presenting cells, e.g. dendritic cells
09 - Scientific and electric apparatus and instruments
Goods & Services
Powered mounting racks specially adapted for holding and
housing pharmaceutical manufacturing machines that are used
for autologous cell therapies comprising a non-disposable
enclosed bioreactor for cell culturing with disposable
units. Mounting racks specially adapted for housing laboratory use
multiple cell therapy micro-bioreactors and also featuring
power supplies and power connectors for use in connection
therewith.
01 - Chemical and biological materials for industrial, scientific and agricultural use
Goods & Services
Cell biology preparations and its components, namely, cell
culture media and feeds for biological and pharmaceutical
laboratory research (term considered too vague by the
International Bureau - Rule 13 (2) (b) of the Regulations).
86.
DETERMINATION OF CONTAMINANTS IN CELL-BASED PRODUCTS WITH FLOW IMAGING MICROSCOPY
The present invention is directed to a method of characterizing sub-visible particles in a cell-based suspension, the method comprising subjecting the cell-based suspension to flow imaging microscopy, collecting images of the sub-visible particles in the cell-based suspension, and then characterizing the sub-visible particles in the images.
09 - Scientific and electric apparatus and instruments
Goods & Services
Electrical or battery-powered mounting racks specially adapted for holding and housing pharmaceutical manufacturing machines that are used for autologous cell therapies comprising a non-disposable enclosed bioreactor for cell culturing with disposable units. Mounting racks specially adapted for housing laboratory and therapeutic use multiple cell therapy micro-bioreactors, and also featuring power supplies and power connectors for use in connection therewith.
09 - Scientific and electric apparatus and instruments
Goods & Services
(1) Mounting racks specially adapted for housing laboratory and therapeutic use multiple cell therapy micro-bioreactors, and also featuring power supplies and power connectors for use in connection therewith; Electrical or battery-powered mounting racks specially adapted for holding and housing pharmaceutical manufacturing machines that are used for autologous cell therapies comprising a non-disposable enclosed bioreactor for cell culturing with disposable units
89.
CELL CONCENTRATION METHODS AND DEVICES FOR USE IN AUTOMATED BIOREACTORS
The present disclosure provides cassettes for use in automated cell engineering systems that include cell concentration filters for reducing fluid volume of a cell sample during or following automated processing. The disclosure also provides methods of concentrating a cell population, as well as automated cell engineering systems that can utilize the cassettes and carry out the methods.
The present disclosure provides cassettes for use in automated cell engineering systems that include cell concentration filters for reducing fluid volume of a cell sample during or following automated processing. The disclosure also provides methods of concentrating a cell population, as well as automated cell engineering systems that can utilize the cassettes and carry out the methods.
The present disclosure provides an automated method of producing viral vectors, utilizing engineered viral vector-producing cell lines within a fully-enclosed cell engineering system. Exemplary viral vectors that can be produced include lentivirus vectors, adeno-associated virus vectors, baculovirus vectors and retrovirus vectors.
09 - Scientific and electric apparatus and instruments
Goods & Services
(1) Powered mounting racks specially adapted for holding and housing pharmaceutical manufacturing machines that are used for autologous cell therapies comprising a non-disposable enclosed bioreactor for cell culturing with disposable units.
(2) Mounting racks specially adapted for housing laboratory use multiple cell therapy micro-bioreactors and also featuring power supplies and power connectors for use in connection therewith.
09 - Scientific and electric apparatus and instruments
Goods & Services
Powered mounting racks specially adapted for holding and housing pharmaceutical manufacturing machines that are used for autologous cell therapies comprising a non-disposable enclosed bioreactor for cell culturing with disposable units Mounting racks specially adapted for housing laboratory use multiple cell therapy micro-bioreactors, and also featuring power supplies and power connectors for use in connection therewith
98.
Adeno-associated virus (AAV) producer cell line and related methods
The present disclosure relates to a mammalian cell line for producing adeno-associated virus (AAV), suitably including nucleic acids encoding helper genes and AAV genes, under the control of derepressible promoters. The disclosure also relates to isolated nucleic acid molecules that encode such genes, as well as methods of using the mammalian cells for producing AAVs.
The present disclosure relates to a mammalian cell line for producing adeno-associated virus (AAV), suitably including nucleic acids encoding helper genes and AAV genes, under the control of derepressible promoters. The disclosure also relates to isolated nucleic acid molecules that encode such genes, as well as methods of using the mammalian cells for producing AAVs.
The present disclosure provides an automated method of producing viral vectors, utilizing engineered viral vector-producing cell lines within a fully-enclosed cell engineering system. Exemplary viral vectors that can be produced include lentivirus vectors, adeno-associated virus vectors, baculovirus vectors and retrovirus vectors.
