GigaGen Publishes Research Showcasing First-Ever Clinical GMP Manufacturing and IND-Enabling Studies for its New Class of Drugs, Recombinant Polyclonal Antibodies
GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immune deficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, announced today the publication of a research article titled, “GMP manufacturing and IND-enabling studies of a recombinant hyperimmune globulin targeting SARS-CoV-2,” in the international, peer-reviewed journal Pathogens. This work showcases for the first time the GMP (good manufacturing practice) manufacturing and IND (Investigational New Drug)-enabling studies of its new class of drugs, recombinant polyclonal antibodies, describing the company’s recombinant polyclonal product that targets SARS-CoV-2, GIGA-2050.
GIGA-2050 is comprised of more than 12,000 antibodies but produced from a single master cell bank (MCB). Prior to GIGA-2050, manufacturing methods for much smaller mixtures of recombinant antibodies often involved the creation of separate MCBs for each monoclonal antibody, followed by mixing the MCBs prior to manufacturing. GIGA-2050 material produced at scales ranging from 3L to 250L had high product quality and consistent yield and potency. Through in vivo studies, GIGA-2050 was shown to be safe and protective against SARS-CoV-2 infection.
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