Waisman Biomanufacturing at the University of Wisconsin–Madison will begin manufacturing a new drug developed by GigaGen to treat and prevent COVID-19.
The therapeutic, called GIGA-2050, uses a new approach similar to treating COVID-19 patients with convalescent plasma, according to Carl Ross, director of Waisman Biomanufacturing.
“Our mission is to support development of novel therapeutics, and we work collaboratively with companies to find ways to manufacture their groundbreaking drugs,” says Ross. “GIGA-2050 is one of the most exciting manufacturing challenges we have encountered.”
The blood of convalescing COVID-19 patients contains antibodies to detect and fight off several variants of SARS-CoV-2. GigaGen, which creates antibody drugs for infectious diseases, transplant rejection, and some cancers, screened blood donated by people recovering from bouts with COVID-19, and found large patient differences in the amounts of different types of coronavirus antibodies.
GIGA-2050 replicates and recombines thousands of the donor antibodies most effective at binding to variants of SARS-CoV-2, and manufactures them so they may be delivered in a uniform, high-potency dose, notes a company spokesperson.
GigaGen reports that in lab tests, GIGA-2050 has been more protective against the virus than convalescent plasma. The company plans to follow those results with phases of testing to ensure safety and track the way the drug is distributed and absorbed in the body. It will run those studies with GIGA-2050 produced by Waisman Biomanufacturing and Goodwin Biotechnology.
Polyclonal drugs have been used for years to successfully treat a range of infectious disease and immunodeficiencies, according to David Johnson, co-founder and CEO of GigaGen. But until now, he adds, they have been produced directly from human and animal plasma.
Cells in Waisman bioreactors will produce antibodies, and the manufacturing center’s scientists will analyze and purify the results and package them as a drug product for use in studies.
“Large-scale manufacturing of GIGA-2050 is a crucial milestone for GigaGen for several reasons,” Johnson says. “It not only puts us on track towards initiation of first-in-human studies for COVID-19 in early 2021, but it demonstrates our ability to execute on novel GMP methods for recombinant polyclonal antibody drugs.