A Mobile BSL-2 cGMP Cleanroom Delivered In Less Than 3 Weeks

Germfree was tasked with providing a mobile cleanroom facility for the manufacturing of a new monoclonal antibody product for phase 1 clinical trials. The facility needed to meet BSL-2 and cGMP requirements and have the potential for future repurposing. The project included a 450 sq. ft size and a 3-room layout, equipped with biosafety cabinets, laminar flow hoods, and pass-through boxes.

The main challenge was to deliver the cleanroom within a tight deadline of less than 3 weeks. However, Germfree was able to modify their standard mobile laboratory platform to meet the specific requirements of the project. The facility was successfully completed within the given timeline and was utilized for the development of a therapeutic for COVID-19. Germfree believes that the mobile cleanroom will continue to be valuable for future clinical trials.