Clinical Phase Manufacturing With Self-Contained Mobile BSL 2 cGMP Cleanroom Facility

Germfree assisted a pharmaceutical client through the development of a mobile Biosafety Level 2+ (BSL-2+) facility adhering to current Good Manufacturing Practices (cGMP) for early-phase clinical trial manufacturing. The facility, designed within a 53-foot semi-tractor trailer, was utilized to manufacture an experimental product for treating mild to moderate COVID-19 cases. Despite the challenges of rapid delivery and cGMP compliance, Germfree successfully built the facility to meet FDA cGMP requirements. The facility, equipped with essential equipment like biosafety cabinets, laminar flow hoods, and PCR workstations, was delivered in a matter of weeks, aiding in the production of high-quality drugs to fight COVID-19. This case demonstrates the potential of mobile facilities in accelerating the production of antibody therapies.