Delivering a BSL-2 and cGMP compliant cleanroom in less than 3 weeks

The extremely rapid client timeline was by far the biggest challenge and required modification from our standard mobile laboratory platform to meet both cGMP and BSL-2 opposed to a ground up custom build. Our engineering team made accommodations for the clients monoclonal antibody (mAbs) therapy development process utilizing total exhaust biological safety cabinets and 3rd party equipment to safely manage material flow in and out of the facility as well as storage.

When our client was working on developing a therapeutic for COVID-19 during the 2020 pandemic, they required a mobile cleanroom facility to prepare clinical trial materials. The mobile facility had to meet both BSL-2 and cGMP requirements and have the potential for future repurposing.

Germfree rose to the challenge and converted our standard 53′ mobile trailer design into a BSL-2 cGMP facility. As part of the standard trailer package, we included equipment like case work, biosafety cabinets, laminar flow hoods, pass-through boxes, autoclaves, and refrigerators. The facility was turned over to the client in less than 21 days, which included commissioning, third-party certification of hoods and facility, FAT, SAT and environmental monitoring testing.

At Germfree, we take great pride in having been a part of such a significant project that aimed to develop a therapeutic for treating COVID-19. It brings us great satisfaction to know that the clinical trials for the mobile facility have been completed. We believe that the mobile cleanroom will be a valuable asset in future clinical trials, and we are confident that our contribution to this project will have a significant impact on the development of effective treatments for COVID-19.

This facility was built on Germfree’s proven mobile biocontainment lab platform, click here to learn more about our Mobile Biocontainment Labs.