In addition to the challenge of speed of delivery, the facility had to meet cGMP requirements, to ensure the safety and quality of production of the investigational drug.

Germfree skillfully designed and built a self-contained BSL-2+ cGMP mobile cleanroom facility within a 53-foot semi-tractor trailer, dedicated to producing an investigational drug targeting mild to moderate COVID-19 cases. Outfitted with an advanced HVAC system and MEP, the facility met rigorous FDA cGMP compliance requirements.

During the initial COVID-19 crisis, Germfree rapidly supplied a stand-alone mobile BSL-2+ cGMP cleanroom for a prominent pharmaceutical company in Indianapolis, IN. Navigating the project’s intricacies, Germfree delivered, factory and site acceptance tested, and commissioned the facility in mere weeks, facilitating prompt, high-quality drug production to fight COVID-19. Germfree’s expertise played a crucial role during the global health emergency, bolstering vital medical research.

The facility featured all essential equipment, such as biosafety cabinets, laminar flow hoods, passthroughs, refrigerators, and PCR workstations. This structure of the facility was built using Germfree’s proven mobile biocontainment lab platform, click here to learn more about our Mobile Biocontainment Labs.