A U.S.-based biotechnology company sought to relocate its manufacturing program from a China-based CDMO to a trusted U.S. Partner. Amid evolving geopolitical tensions, rising tariffs, and growing implications of the BIOSECURE Act, the biotech sponsor wanted to ensure its critical clinical stage biologic program was protected, compliant and future-ready for commercial success.
The molecule, a monoclonal antibody in phase 1 clinical trials had been produced at a 200L scale in China achieving a titer of 5.2 g/L.