AN INTEGRATED PROCESS FOR THE PRODUCTION OF THERAPEUTICS (HUMAN ALBUMIN, INTRAVENOUS IMMUNOGLOBULINS, CLOTTING FACTOR VIII AND CLOTTING FACTOR IX) FROM HUMAN PLASMA

• Main Authors: NUVULA, Ashok, CHAKRABORTY, Zinia, VADDE, Neelima, KOMATH, Uma Devi, DUGGINENI, Swapna Sagar, SAMADDAR, Mitali
• Format: Patent
• Language: English; French; German
• Published: 07.12.2016
• Subjects: BEER; BIOCHEMISTRY; CHEMISTRY; CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION ORPROCESSING OF GOODS; COMPOSITIONS THEREOF; CULTURE MEDIA; ENZYMOLOGY; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; METALLURGY; MICROBIOLOGY; MICROORGANISMS OR ENZYMES; MUTATION OR GENETIC ENGINEERING; ORGANIC CHEMISTRY; PEPTIDES; PERFORMING OPERATIONS; PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; SEPARATION; SPIRITS; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS; TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINSTCLIMATE CHANGE; TRANSPORTING; VINEGAR; WINE

The invention is an integrated process for the isolation and purification of plasma derived clotting Factor VIII, clotting Factor IX, albumin and immunoglobulin without the use of ethanol precipitation. The integrated process comprises of sequential chromatography steps of gel filtration, anion exchange and cation exchange chromatographies, followed by viral inactivation and removal steps. The present invention has the advantage of being a mild process that does not denature or aggregate the proteins and provides high yields of several therapeutic grade plasma proteins from a given volume of plasma.