This mobile facility showcases our expertise in meeting stringent cGMP compliance within a mobile platform. It offers an efficient and rapid solution for Phase I/II clinical trials, encompassing every stage of viral vector production—from cold storage and purification to final formulation before shipment.

Germfree provided an innovative solution by designing and manufacturing a mobile BSL-2LS cGMP facility consisting of 2 prefabricated trailers. The facility includes approximately 900 sq. ft. of cGMP manufacturing and mechanical space. The facility layout incorporates strong segregation to support multiple campaigns occurring at the same time.

Given the nature of starting materials and the substrates/agents being manufactured, this facility was built to meet the Center for Disease Control (CDC) guidelines for Biosafety Level 2 Large Scale (BSL-2LS).

Prefabricated trailers supported the accelerated timeline by manufacturing the cleanrooms while the client prepared the site utilities and support infrastructure. This reduced the overall project duration by several months.

Germfree’s team of experts created a state-of-the-art BSL-2LS cGMP facility that was carefully engineered to provide unidirectional process flow and robust primary engineering controls to ensure a safe and efficient working environment.

This facility was built using Germfree’s proven mobile cleanroom platform, click here to learn more about our mobile cleanrooms!