July 28, 2022
GigaGen Publishes Research Showcasing First-Ever Clinical GMP Manufacturing and IND-Enabling Studies for its New Class of Drugs, Recombinant Polyclonal Antibodies
South San Francisco, Calif., July 28, 2022 (GLOBE NEWSWIRE) -- 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.
Carter Keller, a senior vice president at Grifols and head of GigaGen, commented, “GigaGen’s recombinant polyclonal drugs are a new approach to treating infectious diseases, in particular those best treated by targeting multiple viral epitopes. Our novel manufacturing approach allows us to consistently produce drugs consisting of thousands of antibodies against a virus. We look forward to continuing to leverage our cutting-edge technology and this new class of drugs for the development of medicines for multiple infectious diseases with large unmet need, including our ongoing program for the treatment of the hepatitis B virus (HBV), an infectious disease affecting more than 290 million people worldwide.”