Improved methods for enhancing antibody productivity in mammalian cell culture and minimizing aggregation during downstream, formulation processes and stable antibody formulations obtained thereof

The invention describes an efficient platform for antibody manufacturing and formulation that provides (i) cell culture process with improved feeding strategy resulting in high antibody titer between 2 gm/L to 5 gm/L; (ii) improved purification process showing optimal percentage recovery, high purit...

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Hauptverfasser:	CHOUHAN, PANKAJ SINGH, DHERE, RAJEEV MHALASAKANT, PEDDI, REDDY SRINIVAS REDDY, YEOLEKAR, LEENA RAVINDRA, AVALASKAR, NIKHIL DATTATRAY, PISAL, SAMBHAJI SHANKAR, SINGH, DIGAMBER CHAHAR
Format:	Patent
Sprache:	chi ; eng
Schlagworte:	BEER BIOCHEMISTRY CHEMISTRY COMPOSITIONS THEREOF CULTURE MEDIA ENZYMOLOGY FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIREDCHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERSFROM A RACEMIC MIXTURE HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE METALLURGY MICROBIOLOGY MICROORGANISMS OR ENZYMES MUTATION OR GENETIC ENGINEERING ORGANIC CHEMISTRY PEPTIDES PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS SPIRITS VINEGAR WINE
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Beschreibung
Zusammenfassung:	The invention describes an efficient platform for antibody manufacturing and formulation that provides (i) cell culture process with improved feeding strategy resulting in high antibody titer between 2 gm/L to 5 gm/L; (ii) improved purification process showing optimal percentage recovery, high purity monomer content, minimum aggregation/particulate formation, minimum impurity levels; and (iii) high concentration stable liquid formulation with optimal osmolality and low viscosity across different temperature excursions and devoid of aggregation. The preferred antibodies include IgG1 monoclonal antibody specific to the Dengue virus epitope in domain III of the E protein and IgG1 monoclonal antibody specific to the rabies virus surface G glycoprotein.