The present invention relates to an improved cell culture process for production of proteins with the addition of mitochondria targeted antioxidant to the cell culture. The performance of the cell production is enhanced in aspects of higher viable cell density, protein titer, and reduced oxidation.
The present invention provides an improved assay method for determining the potency of recombinant proteins by culturing tire immune cells such as antigen presenting cell and/or T cell in culture media comprising FBS less than 10%. Furthermore, the invention provides a method to eliminate or reduce tire false estimation of potency of target recombinant protein. The assay method determines the potency of recombinant protein by evaluating the expression of inflammatory protein. More specifically the present invention describes the IL-2 inhibition assays for determination of potency of CTLA4 IgGl .
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
C07K 16/42 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre des immunoglobulines (anticorps anti-idiotypiques)
3.
AN IMPROVED METHOD FOR SEPARATION OF LOW MOLECULAR WEIGHT PROTEINS
The present invention provides the method for the separation of at least more than two Low molecular weight (LMWs) impurities present in the protein mixture comprising fusion protein CTL4-IgGl by using Capillary Electrophoresis-Sodium dodecyl sulfate (CE-SDS) wherein the loading amount of protein mixture is more than 270 pg. The invention further provides a ratio of protein to sodium dodecyl sulfate is 2.7:1 or higher.
G01N 27/26 - Recherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en recherchant des variables électrochimiquesRecherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en utilisant l'électrolyse ou l'électrophorèse
4.
A PROCESS FOR SEPARATION AND QUANTIFICATION OF NON-IONIC SURFACTANT
The present invention relates to a separation and quantification method of a non-ionic surfactant in a composition comprising polypeptide and non-ionic surfactant by using a zwitterionic hydrophilic interaction liquid chromatography (ZIC-HILIC).
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
G01N 30/30 - Contrôle des paramètres physiques du fluide vecteur de la température
A process for purification of antibody or fusion protein by affinity chromatography wherein the elution is performed with high salt concentration which reduce turbidity in protein mixture during neutralization steps. The present invention provides an improved process of purifying antibodies through affinity chromatography using high salt-based elution.
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 15/42 - Adsorption sélective, p. ex. chromatographie caractérisée par le mode de développement, p. ex. par déplacement ou par élution
C07K 16/06 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux provenant de sérum
C07K 16/42 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre des immunoglobulines (anticorps anti-idiotypiques)
6.
AN IMPROVED METHOD FOR SEPARATION OF LOW MOLECULAR WEIGHT PROTEINS
The present invention provides the method for the separation of at least more than two Low molecular weight (LMWs) impurities present in the protein mixture comprising fusion protein CTL4-IgG1 by using Capillary Electrophoresis-Sodium dodecyl sulfate (CE-SDS) wherein the loading amount of protein mixture is more than 270 μg. The invention further provides a ratio of protein to sodium dodecyl sulfate is 2.7:1 or higher.
The present disclosure describes pharmaceutically stable high concentration liquid formulations of antibody. Such formulations comprise, in addition to the antibody, at least one anti-aggregating agent selected from arginine or lysine, buffer and poloxamer 188. In addition, the present disclosure provides high concentrated antibody formulation having high monomer, low aggregates and desirable viscosity.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.
The present invention relates to method of analysis for estimation of relative potency of antibody of interest using β-hexosaminidase degranulation in human cell line. The present invention relates to characterization of functional assay of anti-IgE antibody with B-hexosaminidase.
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
C12Q 1/40 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir une hydrolase une amylase
10.
AN IMPROVED PROCESS FOR PURIFICATION OF FUSION PROTEIN
The present invention relates to purification process of pharmacologically active cytotoxic T lymphocyte-associated 4-immunoglobulin (CTLA4-lg) fusion protein by using three column chromatography steps that provides purified form of the fusion protein, substantially free of misfolded species, charge variants and aggregates. A method for purifying a fusion protein from a protein mixture comprising a fusion protein and high molecular weight (HMW) impurity.
C07K 1/22 - Chromatographie d'affinité ou techniques analogues basées sur des procédés d'absorption sélective
A61K 38/00 - Préparations médicinales contenant des peptides
B01D 15/16 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement relatives au conditionnement du fluide vecteur
B01D 15/32 - Chromatographie en phase liée, p. ex. avec une phase normale liée, une phase inverse ou une interaction hydrophobe
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 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
The present invention relates to a separation and quantification method of a non-ionic surfactant in a composition comprising polypeptide and non-ionic surfactant by using a zwitterionic hydrophilic interaction liquid chromatography (ZIC-HILIC).
The present invention relates to purification process of pharmacologically active IgG1 containing protein comprising at least affinity chromatography followed by mixed-mode chromatography. The present invention provides cytotoxic T-lymphocyte-associated 4-immunoglobulin (CTLA4-Ig) fusion protein by using at least affinity chromatography, mixed-mode chromatography and optionally one or more suitable purification steps that provides purified composition of the fusion protein, substantially free of impurities selected from Pre-Peak, product and process related impurities. Further, the present invention provides highly purified CTLA4-Ig fusion protein with reduced heterogeneity.
C07K 1/16 - ExtractionSéparationPurification par chromatographie
C07K 16/22 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des facteurs de croissance
C07K 16/28 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
The present invention relates to purification process of pharmacologically active IgG1 containing protein comprising at least affinity chromatography followed by mixed-mode chromatography. The present invention provides cytotoxic T-lymphocyte-associated 4-immunoglobulin (CTLA4-Ig) fusion protein by using at least affinity chromatography, mixed-mode chromatography and optionally one or more suitable purification steps that provides purified composition of the fusion protein, substantially free of impurities selected from Pre-Peak, product and process related impurities. Further, the present invention provides highly purified CTLA4-Ig fusion protein with reduced heterogeneity.
The present invention relates to an improved method of quantification and/or estimation of purity of antibody or fusion protein from a protein mixture containing impurity by providing long term sample stability. The invention provides a stable protein solution comprising antibody having reduce formation of Fab and Fc related impurities.
The present invention relates to a process of improving the production of anti-IgE antibody specifically Omalizumab with improved titer and reduced galactosylation and/or reduced acidic variant expressed in mammalian cell culture in suitable culture condition for an example using fed batch mode by maintaining specific temperature 36.5° C.±0.5 throughout the duration of cells culture.
The method disclosed in the current invention is used to increase cell biomass, productivity and protein titer in cell culture medium by using at least more than one fermenter. The method specifically discloses cell culture conditions used in fermenter. More specifically, the method discloses the use of primary and secondary fermenter wherein the primary fermenter comprises different cell culture conditions compared to secondary fermenter.
C12N 5/00 - Cellules non différenciées humaines, animales ou végétales, p. ex. lignées cellulairesTissusLeur culture ou conservationMilieux de culture à cet effet
C07K 16/00 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux
C07K 16/22 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des facteurs de croissance
C12P 21/02 - Préparation de peptides ou de protéines comportant une séquence connue de plusieurs amino-acides, p. ex. glutathion
The invention is directed to room temperature stable injectable formulations of carfilzomib or its pharmaceutically acceptable derivatives thereof in the form of ready to dilute solution and concentrates with no hemolytic potential. Further the invention is directed to a method for treating patients with relapsed or refractory multiple myeloma by administering such composition.
The present invention provides an effective High Performance Liquid Chromatography (SE-HPLC) method to separate or resolve the pre-peak, post-peak and main peak of CTLA4-IgG1 fusion protein, where pre-peak resolution is more than 1.3. The invention further provides effective separation and resolution of post peak impurity present in CTLA4 IgG1 protein. Moreover, the present invention also provides the method for the estimation and/or quantification of pre-peak, post-peak and main peak of the protein mixture.
C07K 1/16 - ExtractionSéparationPurification par chromatographie
B01D 15/34 - Séparation par sélection en fonction de la taille, p. ex. chromatographie d'exclusion de tailleFiltration sur gelPerméation
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 20/283 - Absorbants ou adsorbants poreux à base de silice
C07K 14/705 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire
The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.
The present invention relates to compounds of formula I and therapeutic use of the same. The present invention also discloses pharmaceutical composition of compounds of formula I and method of treatment using the same.
C07D 401/12 - Composés hétérocycliques contenant plusieurs hétérocycles comportant des atomes d'azote comme uniques hétéro-atomes du cycle, au moins un cycle étant un cycle à six chaînons avec un unique atome d'azote contenant deux hétérocycles liés par une chaîne contenant des hétéro-atomes comme chaînons
C07D 401/14 - Composés hétérocycliques contenant plusieurs hétérocycles comportant des atomes d'azote comme uniques hétéro-atomes du cycle, au moins un cycle étant un cycle à six chaînons avec un unique atome d'azote contenant au moins trois hétérocycles
The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.
The present invention relates to novel liquid formulations comprising pharmacologically active fusion protein. The present invention discloses the use of histidine buffer in combination with other excipients to stabilize the fusion protein by lowering the product related impurities. In another aspects invention provides a formulation of fusion protein with low viscosity.
A61K 38/17 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/22 - Composés hétérocycliques, p. ex. acide ascorbique, tocophérol ou pyrrolidones
24.
AN EXTRACTION PROCESS OF PANCRELIPASE AND EVALUATION THREOF
The invention provided herein a pharmaceutical process used for an extraction of proteins from pancreatic sample and estimation of the extracted proteins. Moreover, the invention provides a use of suitable is selected from citrate-phosphate buffer and bicarbonate buffer capable to extract proteins from pancreatic sample. The invention further provides an analytical method to perform estimation of extracted proteins. This process provides an improved extraction method to quantify protein present in the pancreatic sample.
The present invention provides an improved method for analysis of pancreatic protein mixture comprises at least more than one biological active protein selected from amylase, protease and lipase, wherein the analysis and quantification of pancreatic protein mixtures is performed with Size Exclusion High Performance Liquid Chromatography (SE-HPLC). Also, the present invention provides the process for the separation, analysis and quantification of low molecular weight and high molecular weight enzymes present in pancreatic protein mixture.
G01N 33/573 - Tests immunologiquesTests faisant intervenir la formation de liaisons biospécifiquesMatériaux à cet effet pour enzymes ou isoenzymes
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
The present invention relates to a stable liquid composition comprising Ocrelizumab antibody. More specifically, the present invention further provides stable liquid composition does not comprise a hyaluronidase enzyme.
C07K 16/28 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
The present invention relates to a method of analysis for estimation of relative potency of antibody of interest using beta-hexosaminidase degranulation in human cell line. The present invention relates to characterization of functional assay of anti-lgE antibody with beta-hexosaminidase. Every area of the biomedical science is in need of a system to assay chemical and biochemical reactions and determine the presence and quantity of a particular analyte. Numerous methodologies have been developed over the years to meet the demands of these fields. In general, limitations exist in the areas of specificity and sensitivity of most assay system.
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
G01N 33/50 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique
28.
ANTI-VERTIGO COMPOUND AND PHARMACEUTICAL COMPOSITIONS THEREOF
The present invention relates to uses of Levocloperastine for the treatment or prevention of vertigo, disease associated with vertigo or symptoms associated therewith. Further, the invention also relates to oral pharmaceutical composition comprising Levocloperastine and one or more pharmaceutical excipients and its preparation process.
A61K 31/4453 - Pipéridines non condensées, p. ex. pipérocaïne substituées uniquement en position 1, p. ex. propipocaïne, dipérodone
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61P 1/08 - Médicaments pour le traitement des troubles du tractus alimentaire ou de l'appareil digestif des nausées, du mal des transports ou des vertigesAntiémétiques
29.
AN IMPROVED PROCESS OF STORING AND PREPARING THE PROTEIN
The present invention provides a method for reducing the protein aggregation by adjusting the pH below 6.0 of liquid formulation comprising the antibody or fusion protein. The present invention also provides methods for storing the pre-formulation for longer period without using any sugar or additives which can be utilized for preparation of liquid or lyophilized formulation.
C07K 1/16 - ExtractionSéparationPurification par chromatographie
C07K 16/42 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre des immunoglobulines (anticorps anti-idiotypiques)
A61K 47/54 - Préparations médicinales caractérisées par les ingrédients non actifs utilisés, p. ex. les supports ou les additifs inertesAgents de ciblage ou de modification chimiquement liés à l’ingrédient actif l’ingrédient non actif étant chimiquement lié à l’ingrédient actif, p. ex. conjugués polymère-médicament l’ingrédient non actif étant un agent de modification l’agent de modification étant un composé organique
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/36 - PolysaccharidesLeurs dérivés, p. ex. gommes, amidon, alginate, dextrine, acide hyaluronique, chitosane, inuline, agar-agar ou pectine
A61K 47/34 - Composés macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyesters, acides polyaminés, polysiloxanes, polyphosphazines, copolymères de polyalkylène glycol ou de poloxamères
30.
PROCESS FOR PREPARATION OF STABLE PROTEIN SOLUTION
The present invention relates to an improved method of quantification and/or estimation of purity of antibody or fusion protein from a protein mixture containing impurity by providing long term sample stability. The invention provides a stable protein solution comprising antibody having reduce formation of Fab and Fc related impurities.
An improved cell culture process for production of protein The present invention relates to an improved cell culture process for production of proteins with the addition of mitochondria targeted antioxidant to the cell culture. The performance of the cell production is enhanced in aspects of higher viable cell density, protein titer, and reduced oxidation.
Title: A Method for separating and detecting of free or residual polyethylene glycol in Pegylated proteins. The present invention relates to an improved method for separating and detecting of free or residual polyethylene glycol (PEG) in pegylated protein mixture. In particular, the method improves sensitivity, effective separation, and robustness of the quantification of free or residual PEG and related substance present in pegylated protein mixture which obtained as drug substance or drug product.
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
34.
IMPROVED PROCESS FOR THE SEPARATION AND ANALYSIS OF PANCREATIC ENZYMES
The present invention relates to reversed phase ultrahigh-performance liquid chromatography (RP-UHPLC) process by using C18 column at a suitable more than one gradient of mobile phase useful for the separation and characterisation of pancreatic protein mixture comprising at least one enzyme lipase, amylase, protease and variant thereof. The present invention further provides qualitative and quantitative analysis of separated Pancreatic protein mixture suitable for pharmaceutical use.
Title: An improved process for the separation and analysis of pancreatic enzymes. The present invention relates to reversed phase ultrahigh-performance liquid chromatography (RP- UHPLC) process by using C18 column at a suitable more than one gradient of mobile phase useful for the separation and characterisation of pancreatic protein mixture comprising at least one enzyme lipase, amylase, protease and variant thereof. The present invention further provides qualitative and quantitative analysis of separated Pancreatic protein mixture suitable for pharmaceutical use.
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
The present invention relates to a process of improving the production of anti-IgE antibody specifically Omalizumab with improved titer and reduced galactosylation and/or reduced acidic variant expressed in mammalian cell culture in suitable culture condition for an example using fed batch mode by maintaining specific temperature 36.5° C ± 0.5 throughout the duration of cells culture.
C12P 21/00 - Préparation de peptides ou de protéines
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
C12N 5/00 - Cellules non différenciées humaines, animales ou végétales, p. ex. lignées cellulairesTissusLeur culture ou conservationMilieux de culture à cet effet
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
37.
A PROCESS FOR SEPARATION AND QUANTIFICATION OF NON-IONIC SURFACTANT
The present invention relates to a separation and quantification method of a non-ionic surfactant in a composition comprising polypeptide and non-ionic surfactant by using a zwitterionic hydrophilic interaction liquid chromatography (ZIC-HILIC).
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
G01N 30/30 - Contrôle des paramètres physiques du fluide vecteur de la température
38.
AN IMPROVED METHOD FOR SEPARATION OF LOW MOLECULAR WEIGHT PROTEINS
The present invention provides the method for the separation of at least more than two Low molecular weight (LMWs) impurities present in the protein mixture comprising fusion protein CTL4-IgG1 by using Capillary Electrophoresis-Sodium dodecyl sulfate (CE-SDS) wherein the loading amount of protein mixture is more than 270 µg. The invention further provides a ratio of protein to sodium dodecyl sulfate is 2.7:1 or higher.
G01N 27/26 - Recherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en recherchant des variables électrochimiquesRecherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en utilisant l'électrolyse ou l'électrophorèse
The present invention provides an improved assay method for determining the potency of recombinant proteins by culturing the immune cells such as antigen presenting cell and/or T cell in culture media comprising FBS less than 10%. Furthermore, the invention provides a method to eliminate or reduce the false estimation of potency of target recombinant protein. The assay method determines the potency of recombinant protein by evaluating the expression of inflammatory protein. More specifically the present invention describes the IL-2 inhibition assays for determination of potency of CTLA4 IgG1.
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
The present invention relates to novel compounds or pharmaceutically acceptable salts thereof, useful for the treatment of cancer. The present disclosure also relates to pharmaceutical composition of the novel compound and method of treating benign or malignant disease of the breast or reproductive tract, prostate cancer, or endometrial cancer using the same.
A61K 31/58 - Composés contenant des systèmes cycliques du cyclopenta[a]hydrophénanthrèneLeurs dérivés, p. ex. stéroïdes contenant des hétérocycles, p. ex. danazol, stanozolol, pancuronium ou digitogénine
41.
MULTICISTRON EXPRESSION VECTOR FOR COVID-19 VACCINE
The present invention provides an expression vector comprises gene of interest encode more than one structural protein to enhance immune responses against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and its variants. Further, the present invention the expression vector comprises spike protein of SARS-CoV-2 and one or more structural protein selected from membrane protein, envelope protein and nucleocapsid protein of SARS-CoV-2. The expression vector expressed mRNA capable to encode more than one structural protein to provide immune response against SARS-CoV-2 virus.
A process for purification of antibody or fusion protein by affinity chromatography wherein the elution is performed with high salt concentration which reduce turbidity in protein mixture during neutralization steps. The present invention provides an improved process of purifying antibodies through affinity chromatography using high salt-based elution.
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 15/42 - Adsorption sélective, p. ex. chromatographie caractérisée par le mode de développement, p. ex. par déplacement ou par élution
C07K 16/06 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux provenant de sérum
C07K 16/42 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre des immunoglobulines (anticorps anti-idiotypiques)
The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.
A process for purification of antibody or fusion protein through anion exchange chromatography to produce an antibody or fusion protein which is substantially free of at least one of the product-related impurities.
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 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
The invention provides room temperature stable ready to dilute injectable formulation comprising carfilzomib or it pharmaceutically acceptable derivatives. The invention further provides methods for treating patients with multiple myeloma by administering room temperature stable ready to dilute injectable formulations comprising carfilzomib or its pharmaceutically acceptable derivatives.
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 47/22 - Composés hétérocycliques, p. ex. acide ascorbique, tocophérol ou pyrrolidones
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
The present invention provides an expression vector comprises gene of interest encode more than one structural protein to enhance immune responses against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and its variants. Furthermore, the expression vector to produce mRNA expresses more than one structural protein to generate immune response against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and its variants.
The present invention relates to Fulvestrant prodrugs and process for the preparation thereof. The present disclosure also relates to pharmaceutical composition of Fulvestrant prodrugs and method of treatment using the same.
C07J 43/00 - Stéroïdes normaux ayant un hétérocycle contenant de l'azote non condensé ou condensé en spiro avec le squelette du cyclopenta[a]hydrophénanthrène
C07J 31/00 - Stéroïdes normaux contenant un ou plusieurs atomes de soufre n'appartenant pas à un hétérocycle
C07J 41/00 - Stéroïdes normaux contenant un ou plusieurs atomes d'azote n'appartenant pas à un hétérocycle
48.
INECTABLE PHARMACEUTICAL COMPOSITION FOR TREATMENT OF BREAST CANCER
The invention relates to an injectable composition comprising compound I, pharmaceutically acceptable salts or solvates thereof; and at least one pharmaceutically acceptable excipient, wherein the injectable composition provides sustained release of compound I and thereby maintains blood plasma fulvestrant concentration. Also, the present invention used for method of treatment of breast cancer comprising compound of formula I, pharmaceutically acceptable salts or solvates thereof; and at least one pharmaceutically acceptable excipient.
A61K 31/565 - Composés contenant des systèmes cycliques du cyclopenta[a]hydrophénanthrèneLeurs dérivés, p. ex. stéroïdes non substitués en position 17 bêta par un atome de carbone, p. ex. œstrane, œstradiol
The invention is directed to room temperature stable injectable formulations of carfilzomib or its pharmaceutically acceptable derivatives thereof in the form of ready to dilute solution and concentrates with no hemolytic potential. Further the invention is directed to a method for treating patients with relapsed or refractory multiple myeloma by administering such composition.
The invention is directed to room temperature stable injectable formulations of carfilzomib or its pharmaceutically acceptable derivatives thereof in the form of ready to dilute solution and concentrates with no hemolytic potential. Further the invention is directed to a method for treating patients with relapsed or refractory multiple myeloma by administering such composition.
The present invention provides an effective High Performance Liquid Chromatography (SE-HPLC) method to separate or resolve the pre-peak and main peak (fusion protein). The method provides improved sharpness and resolution of pre-peak impurity. The method provides pre-peak area not less than 1.0 and resolution more than 1.3 in SE-HPLC. Moreover, the present invention also provides the method for the estimation and/or quantification of pre-peak and main peak of the protein mixture.
B01D 15/34 - Séparation par sélection en fonction de la taille, p. ex. chromatographie d'exclusion de tailleFiltration sur gelPerméation
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
C07K 16/28 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
52.
SEPARATION OF PRE-PEAK AND POST-PEAK IN FUSION PROTEIN SAMPLE BY USING SIZE EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
The present invention provides an effective High Performance Liquid Chromatography (SE-HPLC) method to separate or resolve the pre-peak, post-peak and main peak of CTLA4-IgG1 fusion protein, where pre-peak resolution is more than 1.3. The invention further provides effective separation and resolution of post peak impurity present in CTLA4 IgG1 protein. Moreover, the present invention also provides the method for the estimation and/or quantification of pre-peak, post-peak and main peak of the protein mixture.
B01D 15/34 - Séparation par sélection en fonction de la taille, p. ex. chromatographie d'exclusion de tailleFiltration sur gelPerméation
C07K 16/28 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
53.
SEPARATION OF PRE-PEAK IN FUSION PROTEIN SAMPLE BY USING SIZE EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
The present invention provides an effective High Performance Liquid Chromatography (SE-HPLC) method to separate or resolve the pre-peak and main peak (fusion protein). The method provides improved sharpness and resolution of pre-peak impurity. The method provides pre-peak area not less than 1.0 and resolution more than 1.3 in SE-HPLC. Moreover, the present invention also provides the method for the estimation and/or quantification of pre-peak and main peak of the protein mixture.
B01D 15/34 - Séparation par sélection en fonction de la taille, p. ex. chromatographie d'exclusion de tailleFiltration sur gelPerméation
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
C07K 16/28 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
54.
SEPARATION OF PRE-PEAK AND POST-PEAK IN FUSION PROTEIN SAMPLE BY USING SIZE EXCLUSION HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
The present invention provides an effective High Performance Liquid Chromatography (SE-HPLC) method to separate or resolve the pre-peak, post-peak and main peak of CTLA4-IgG1 fusion protein, where pre-peak resolution is more than 1.3. The invention further provides effective separation and resolution of post peak impurity present in CTLA4 IgG1 protein. Moreover, the present invention also provides the method for the estimation and/or quantification of pre-peak, post-peak and main peak of the protein mixture.
B01D 15/34 - Séparation par sélection en fonction de la taille, p. ex. chromatographie d'exclusion de tailleFiltration sur gelPerméation
C07K 16/28 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux contre du matériel provenant d'animaux ou d'humains contre des récepteurs, des antigènes de surface cellulaire ou des déterminants de surface cellulaire
The present invention relates to purification process of pharmacologically active IgG1 containing protein comprising at least affinity chromatography followed by mixed-mode chromatography. The present invention providescytotoxic T-lymphocyte-associated 4-immunoglobulin (CTLA4-Ig) fusion protein by using at least affinity chromatography, mixed-mode chromatography and optionally one or more suitable purification steps that provides purified composition of the fusion protein, substantially free of impurities selected from Pre-Peak, product and process related impurities. Further, the present invention provides highly purified CTLA4-Ig fusion protein with reduced heterogeneity.
The present invention relates to purification process of pharmacologically active IgG1 containing protein comprising at least affinity chromatography followed by mixed-mode chromatography. The present invention providescytotoxic T-lymphocyte-associated 4-immunoglobulin (CTLA4-Ig) fusion protein by using at least affinity chromatography, mixed-mode chromatography and optionally one or more suitable purification steps that provides purified composition of the fusion protein, substantially free of impurities selected from Pre-Peak, product and process related impurities. Further, the present invention provides highly purified CTLA4-Ig fusion protein with reduced heterogeneity.
The present invention relates to purification process of pharmacologically active cytotoxic T lymphocyte-associated 4-immunoglobulin (CTLA4-lg) fusion protein by using three column chromatography steps that provides purified form of the fusion protein, substantially free of misfolded species, charge variants and aggregates. A method for purifying a fusion protein from a protein mixture comprising a fusion protein and high molecular weight (HMW) impurity.
A61K 38/17 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
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 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
C07K 1/16 - ExtractionSéparationPurification par chromatographie
The present invention relates to purification process of pharmacologically active cytotoxic T lymphocyte-associated 4-immunoglobulin (CTLA4-lg) fusion protein by using three column chromatography steps that provides purified form of the fusion protein, substantially free of misfolded species, charge variants and aggregates. A method for purifying a fusion protein from a protein mixture comprising a fusion protein and high molecular weight (HMW) impurity.
C07K 16/06 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux provenant de sérum
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 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
The present invention relates to an improved method of quantification and/or estimation of purity of antibody or fusion protein from a protein mixture containing impurity by providing long term sample stability. The invention provides a stable protein solution comprising antibody having reduce formation of Fab and Fc related impurities.
The present invention relates to an improved method of quantification and/or estimation of purity of antibody or fusion protein from a protein mixture containing impurity by providing long term sample stability. The invention provides a stable protein solution comprising antibody having reduce formation of Fab and Fc related impurities.
C07K 1/16 - ExtractionSéparationPurification par chromatographie
C07K 16/00 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux
C12P 21/06 - Préparation de peptides ou de protéines préparés par hydrolyse d'une liaison peptidique, p. ex. hydrolysats
C12Q 1/37 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir une hydrolase faisant intervenir une peptidase ou une protéinase
G01N 1/28 - Préparation d'échantillons pour l'analyse
The present invention relates to a determination of antagonist effect of desired compound useful in the inhibition of activity of bradykinin receptors. Furthermore, the present invention provides an improved assay method to determine the efficacy of desired compounds by inhibiting the activity of bradykinin receptors. More specifically the present invention provides an improved assay method, wherein desired antagonistic effect of the compounds is determined by measuring intracellular calcium release.
G01N 33/50 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
64.
AN EXTRACTION PROCESS OF PANCRELIPASE AND EVALUATION THREOF
The invention provided herein a pharmaceutical process used for an extraction of proteins from pancreatic sample and estimation of the extracted proteins. Moreover, the invention provides a use of suitable is selected from citrate-phosphate buffer and bicarbonate buffer capable to extract proteins from pancreatic sample. The invention further provides an analytical method to perform estimation of extracted proteins. This process provides an improved extraction method to quantify protein present in the pancreatic sample.
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
65.
AN EXTRACTION PROCESS OF PANCRELIPASE AND EVALUATION THREOF
The invention provided herein a pharmaceutical process used for an extraction of proteins from pancreatic sample and estimation of the extracted proteins. Moreover, the invention provides a use of suitable is selected from citrate-phosphate buffer and bicarbonate buffer capable to extract proteins from pancreatic sample. The invention further provides an analytical method to perform estimation of extracted proteins. This process provides an improved extraction method to quantify protein present in the pancreatic sample.
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
The present invention provides an improved method for analysis of pancreatic protein mixture comprises at least more than one biological active protein selected from amylase, protease and lipase, wherein the analysis and quantification of pancreatic protein mixtures is performed with Size Exclusion High Performance Liquid Chromatography (SE-HPLC). Also, the present invention provides the process for the separation, analysis and quantification of low molecular weight and high molecular weight enzymes present in pancreatic protein mixture.
G01N 33/48 - Matériau biologique, p. ex. sang, urineHémocytomètres
G01N 33/50 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique
67.
METHOD FOR SIZE BASED EVALUATION OF PANCREATIC PROTEIN MIXTURE
The present invention provides an improved method for analysis of pancreatic protein mixture comprises at least more than one biological active protein selected from amylase, protease and lipase, wherein the analysis and quantification of pancreatic protein mixtures is performed with Size Exclusion High Performance Liquid Chromatography (SE-HPLC). Also, the present invention provides the process for the separation, analysis and quantification of low molecular weight and high molecular weight enzymes present in pancreatic protein mixture.
G01N 33/48 - Matériau biologique, p. ex. sang, urineHémocytomètres
G01N 33/50 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique
The present invention relates to novel liquid formulations comprising pharmacologically active fusion protein. The present invention discloses the use of histidine buffer in combination with other excipients to stabilize the fusion protein by lowering the product related impurities. In another aspects invention provides a formulation of fusion protein with low viscosity.
A61K 38/17 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
C07K 14/71 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des facteurs de croissanceRécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des régulateurs de croissance
The present invention relates to novel liquid formulations comprising pharmacologically active fusion protein. The present invention discloses the use of histidine buffer in combination with other excipients to stabilize the fusion protein by lowering the product related impurities. In another aspects invention provides a formulation of fusion protein with low viscosity.
A61K 38/17 - Peptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'animauxPeptides ayant plus de 20 amino-acidesGastrinesSomatostatinesMélanotropinesLeurs dérivés provenant d'humains
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
C07K 14/71 - RécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des facteurs de croissanceRécepteursAntigènes de surface cellulaireDéterminants de surface cellulaire pour des régulateurs de croissance
The present invention relates to compounds useful as bradykinin receptor antagonist, pharmaceutical composition comprising such compounds, and therapeutic use of the same. The present invention further relates to the combination of compounds useful for the therapeutic use. The present invention relates to the pharmaceutical composition comprising the compound and combination of compounds useful for treatment of urinary bladder pain, the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters.
The present invention relates to compounds of formula I and therapeutic use of the same. The present invention also discloses pharmaceutical composition of compounds of formula I and method of treatment using the same.
The present disclosure describes pharmaceutically stable high concentration liquid formulations of antibody. Such formulations comprise, in addition to the antibody, at least one anti-aggregating agent selected from arginine or lysine, buffer and poloxamer 188. In addition, the present disclosure provides high concentrated antibody formulation having high monomer, low aggregates and desirable viscosity.
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
73.
A PROCESS FOR SEPARATION AND QUANTITATION OF PROTEINS USING CAPILLARY ELECTROPHORESIS
The present disclosure provides a method for analyzing, detecting and separating at least one low molecular weight impurity from a protein mixture using capillary electrophoresis, e.g., capillary electrophoresis-sodium dodecyl sulfate (CE-SDS). The present disclosure further provides methods to improve protein peak separation efficiency and quantification of a protein. Furthermore, the present disclosure provides an improved reduced CE-SDS method for analyzing a protein mixture comprising protein of interest which is pegylated and separates LMW or HMW fragments present in the protein mixture.
The present disclosure provides self-regulating, oral, osmotic, floating gastroretentive CD/LD compositions that are suitable for once- or twice-daily administration. The compositions provide extended release with enhanced pharmacokinetic attributes of LD, e.g., reduced lag time, avoidance of low trough levels, and reduced peak-to-trough ratios (Cmax/Cmin) compared to marketed CD/LD products. The compositions provide extended release of CD/LD for about 8 to about 14 hours, without losing gastroretentive attributes of the system (GRS attributes), and collapse/squeeze after at least about 80% of the drug (CD/LD) is released from the system. The compositions of the disclosure, when consumed or when in contact with media simulating gastric conditions, float in about 45 minutes or less, swell in about 60 minutes or less to a swollen state that prevents their passage through the pyloric sphincter, and remain in the swollen state, while releasing steady therapeutic concentrations of the drug, for prolonged periods, e.g., about 8-14 hours.
The present invention provides a method for reducing the protein aggregation by adjusting the pH below 6.0 of liquid formulation comprising the antibody or fusion protein. The present invention also provides methods for storing the pre-formulation for longer period without using any sugar or additives which can be utilized for preparation of liquid or lyophilized formulation.
A61K 9/19 - Préparations médicinales caractérisées par un aspect particulier à l'état particulaire, p. ex. poudres lyophilisées
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/14 - Esters d’acides carboxyliques, p. ex. acides gras monoglycérides, triglycérides à chaine moyenne, parabènes ou esters d’acide gras de PEG
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
C07K 16/00 - Immunoglobulines, p. ex. anticorps monoclonaux ou polyclonaux
79.
AN IMPROVED PROCESS OF STORING AND PREPARING THE PROTEIN
The present invention provides a method for reducing the protein aggregation by adjusting the pH below 6.0 of liquid formulation comprising the antibody or fusion protein. The present invention also provides methods for storing the pre-formulation for longer period without using any sugar or additives which can be utilized for preparation of liquid or lyophilized formulation.
A61K 9/19 - Préparations médicinales caractérisées par un aspect particulier à l'état particulaire, p. ex. poudres lyophilisées
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A process for purification of antibody or fusion protein through anion exchange chromatography to produce an antibody or fusion protein which is substantially free of at least one of the product-related impurities.
A process for purification of antibody or fusion protein by affinity chromatography wherein the elution is performed with high salt concentration which reduce turbidity in protein mixture during neutralization steps. The present invention provides an improved process of purifying antibodies through affinity chromatography using high salt-based elution.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
B01D 12/00 - Déplacement d'un liquide au moyen d'un autre liquide, p. ex. en retirant le liquide de solides humides, ou de dispersions de liquides, ou de solides se trouvant dans des liquides
B01D 15/08 - Adsorption sélective, p. ex. chromatographie
B01D 15/10 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement
The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.
The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.
A process for purification of antibody or fusion protein through anion exchange chromatography to produce an antibody or fusion protein which is substantially free of at least one of the product-related impurities.
A process for purification of antibody or fusion protein by affinity chromatography wherein the elution is performed with high salt concentration which reduce turbidity in protein mixture during neutralization steps. The present invention provides an improved process of purifying antibodies through affinity chromatography using high salt-based elution.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
B01D 12/00 - Déplacement d'un liquide au moyen d'un autre liquide, p. ex. en retirant le liquide de solides humides, ou de dispersions de liquides, ou de solides se trouvant dans des liquides
B01D 15/08 - Adsorption sélective, p. ex. chromatographie
B01D 15/10 - Adsorption sélective, p. ex. chromatographie caractérisée par des caractéristiques de structure ou de fonctionnement
86.
STABLE READY TO DILUTE FORMULATIONS OF CARFILZOMIB
The invention provides room temperature stable ready to dilute injectable formulation comprising carfilzomib or it pharmaceutically acceptable derivatives. The invention further provides methods for treating patients with multiple myeloma by administering room temperature stable ready to dilute injectable formulations comprising carfilzomib or its pharmaceutically acceptable derivatives.
The invention provides room temperature stable ready to dilute injectable formulation comprising carfilzomib or it pharmaceutically acceptable derivatives. The invention further provides methods for treating patients with multiple myeloma by administering room temperature stable ready to dilute injectable formulations comprising carfilzomib or its pharmaceutically acceptable derivatives.
The present invention relates to Fulvestrant prodrugs and process for the preparation thereof. The present disclosure also relates to pharmaceutical composition of Fulvestrant prodrugs and method of treatment using the same.
A61K 31/565 - Composés contenant des systèmes cycliques du cyclopenta[a]hydrophénanthrèneLeurs dérivés, p. ex. stéroïdes non substitués en position 17 bêta par un atome de carbone, p. ex. œstrane, œstradiol
C07J 51/00 - Stéroïdes normaux à squelette du cyclopenta[a]hydrophénanthrène non modifié non prévus dans les groupes
The present disclosure describes pharmaceutically stable high concentration liquid formulations of antibody. Such formulations comprise, in addition to the antibody, at least one anti-aggregating agent selected from arginine or lysine, buffer and poloxamer 188. In addition, the present disclosure provides high concentrated antibody formulation having high monomer, low aggregates and desirable viscosity.
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/24 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant des atomes autres que des atomes de carbone, d'hydrogène, d'oxygène, d'halogènes, d'azote ou de soufre, p. ex. cyclométhicone ou phospholipides
The present invention relates to compounds useful as bradykinin receptor antagonist, pharmaceutical composition comprising such compounds, and therapeutic use of the same. The present invention further relates to the combination of compounds useful for the therapeutic use. The present invention relates to the pharmaceutical composition comprising the compound and combination of compounds useful for treatment of urinary bladder pain, the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters.
A61K 31/4439 - Pyridines non condenséesLeurs dérivés hydrogénés contenant d'autres systèmes hétérocycliques contenant un cycle à cinq chaînons avec l'azote comme hétéro-atome du cycle, p. ex. oméprazole
C07D 413/04 - Composés hétérocycliques contenant plusieurs hétérocycles, au moins un cycle comportant des atomes d'azote et d'oxygène comme uniques hétéro-atomes du cycle contenant deux hétérocycles liés par une liaison directe de chaînon cyclique à chaînon cyclique
92.
NOVEL FORMULATION OF HIGHLY CONCENTRATED PHARMACOLOGICALLY ACTIVE ANTIBODY
The present disclosure describes pharmaceutically stable high concentration liquid formulations of antibody. Such formulations comprise, in addition to the antibody, at least one anti-aggregating agent selected from arginine or lysine, buffer and poloxamer 188. In addition, the present disclosure provides high concentrated antibody formulation having high monomer, low aggregates and desirable viscosity.
A61K 39/395 - AnticorpsImmunoglobulinesImmunsérum, p. ex. sérum antilymphocitaire
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/18 - AminesAmidesUréesComposés d’ammonium quaternaireAcides aminésOligopeptides ayant jusqu’à cinq acides aminés
A61K 47/24 - Composés organiques, p. ex. hydrocarbures naturels ou synthétiques, polyoléfines, huile minérale, gelée de pétrole ou ozocérite contenant des atomes autres que des atomes de carbone, d'hydrogène, d'oxygène, d'halogènes, d'azote ou de soufre, p. ex. cyclométhicone ou phospholipides
The present disclosure provides a method for analyzing, detecting and separating at least one low molecular weight impurity from a protein mixture using capillary electrophoresis, e.g., capillary electrophoresis - sodium dodecyl sulfate (CE-SDS). The present disclosure further provides methods to improve protein peak separation efficiency and quantification of a protein. Furthermore, the present disclosure provides an improved reduced CE-SDS method for analyzing a protein mixture comprising protein of interest which is pegylated and separates LMW or HMW fragments present in the protein mixture.
C12Q 1/04 - Détermination de la présence ou du type de micro-organismeEmploi de milieux sélectifs pour tester des antibiotiques ou des bactéricidesCompositions à cet effet contenant un indicateur chimique
C12Q 1/70 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir des virus ou des bactériophages
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
The present disclosure provides a method for analyzing, detecting and separating at least one low molecular weight impurity from a protein mixture using capillary electrophoresis, e.g., capillary electrophoresis - sodium dodecyl sulfate (CE-SDS). The present disclosure further provides methods to improve protein peak separation efficiency and quantification of a protein. Furthermore, the present disclosure provides an improved reduced CE-SDS method for analyzing a protein mixture comprising protein of interest which is pegylated and separates LMW or HMW fragments present in the protein mixture.
C12P 21/00 - Préparation de peptides ou de protéines
C12Q 1/70 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir des virus ou des bactériophages
G01N 27/26 - Recherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en recherchant des variables électrochimiquesRecherche ou analyse des matériaux par l'emploi de moyens électriques, électrochimiques ou magnétiques en utilisant l'électrolyse ou l'électrophorèse
G01N 33/68 - Analyse chimique de matériau biologique, p. ex. de sang ou d'urineTest par des méthodes faisant intervenir la formation de liaisons biospécifiques par ligandsTest immunologique faisant intervenir des protéines, peptides ou amino-acides
95.
GASTRORETENTIVE DOSAGE FORMS OF LEVODOPA AND CARBIDOPA
maxminmin) compared to marketed CD/LD products. The compositions provide extended release of CD/LD for about 8 to about 14 hours, without losing gastroretentive attributes of the system (GRS attributes), and collapse/squeeze after at least about 80% of the drug (CD/LD) is released from the system. The compositions of the disclosure, when consumed or when in contact with media simulating gastric conditions, float in about 45 minutes or less, swell in about 60 minutes or less to a swollen state that prevents their passage through the pyloric sphincter, and remain in the swollen state, while releasing steady therapeutic concentrations of the drug, for prolonged periods, e.g., about 8-14 hours.
The present disclosure provides programmable osmotic-controlled oral compositions providing delayed extended release of a therapeutically acceptable amount of methylphenidate hydrochloride. The programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, and volume of gastric fluid. The compositions of the disclosure can be programmed to provide a desired and precise lag time, and release drug, after the lag time, at a rhythm that matches the circadian rhythm of an individual being treated to optimize therapeutic outcome and minimize side effects.
The present invention relates to a pharmaceutical composition comprising glucosylceramide synthase inhibitor and a one or more pharmaceutically acceptable excipients. The present invention specifically relates to a sublingual pharmaceutical composition of eliglustat or a pharmaceutically acceptable salt thereof and a one or more pharmaceutically acceptable excipients. Moreover, the present invention further relates to a pharmaceutical composition of eliglustat or a pharmaceutically acceptable salt thereof which is used in the treatment of individual with lysozymal storage diseases selected from the group consisting of, Gaucher disease, Sphingolipidoses, Farber disease, Krabbe disease, Fabry disease, Schindler disease, Tay-Sachs disease and Niemann-Pick disease.
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
A61K 31/4025 - Composés hétérocycliques ayant l'azote comme hétéro-atome d'un cycle, p. ex. guanéthidine ou rifamycines ayant des cycles à cinq chaînons avec un azote comme seul hétéro-atome d'un cycle, p. ex. sulpiride, succinimide, tolmétine, buflomédil non condensés et contenant d'autres hétérocycles, p. ex. cromakalim
98.
Stable oral pharmaceutical composition of imatinib
The present invention relates to a stable orally disintegrating pharmaceutical formulation comprising imatinib or a pharmaceutically acceptable salt thereof and a one or more pharmaceutically acceptable excipients. The present invention further relates to a stable dispersible pharmaceutical formulation comprising imatinib or a pharmaceutically acceptable salt thereof, and a one or more pharmaceutically acceptable excipients. Moreover, the present invention also relates to a novel pharmaceutical sachet formulation comprising an effective amount of imatinib or a pharmaceutically acceptable salt thereof, a flavouring agent, a sweetener and a one or more pharmaceutically acceptable excipients.
The present invention relates to a pharmaceutical composition comprising glucosylceramide synthase inhibitor and a one or more pharmaceutically acceptable excipients. The present invention specifically relates to a sublingual pharmaceutical composition of eliglustat or a pharmaceutically acceptable salt thereof and a one or more pharmaceutically acceptable excipients. Moreover, the present invention further relates to a pharmaceutical composition of eliglustat or a pharmaceutically acceptable salt thereof which is used in the treatment of individual with lysozymal storage diseases selected from the group consisting of, Gaucher disease, Sphingolipidoses, Farber disease, Krabbe disease, Fabry disease, Schindler disease, Tay-Sachs disease and Niemann-Pick disease.
A61K 31/4025 - Composés hétérocycliques ayant l'azote comme hétéro-atome d'un cycle, p. ex. guanéthidine ou rifamycines ayant des cycles à cinq chaînons avec un azote comme seul hétéro-atome d'un cycle, p. ex. sulpiride, succinimide, tolmétine, buflomédil non condensés et contenant d'autres hétérocycles, p. ex. cromakalim
A61K 9/00 - Préparations médicinales caractérisées par un aspect particulier
maxminmaxmax ratio of ≥ 0.4, while maintaining a therapeutically effective concentration for a period of at least about 16 hours. The compositions of the disclosure improve solubility of trihexyphenidyl hydrochloride, at a pH of greater than or equal to 5, to maintain its minimum effective concentration at such pH. In certain embodiments, the compositions of the disclosure comprise an IR drug layer to provide extended release with a minimal lag time, while maintaining a therapeutically effective concentration of trihexyphenidyl hydrochloride for a period of at least about 16 hours.
