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Mobile Pharmaceutical cGMP Cleanroom

This Mobile BSL-2+ cGMP Biocontainment Cleanroom is self-contained on a semi-trailer (420 ft2 / 39 m2 gross area). This facility was designed for the cGMP production of an investigational drug for a novel antibody therapy for treatment of mild to moderate COVID-19 illness. This project was delivered, commissioned, and qualified in Indianapolis, IN within weeks of kick-off to serve the needs of the global pandemic. Germfree’s bioGO® Mobile Cleanrooms and Biocontainment Suites are available in standard and custom configurations to meet a wide variety of cGMP development, manufacturing, and aseptic training applications. Each facility is engineered and constructed to meet or exceed the current US and EU Good Manufacturing Practices, ISPE Baseline Guides®, ISO 14644, CDC NIH BMBL guidelines for BSL Laboratories, and other relevant standards. Our mobile (trailer/vehicle-based) units deliver critical cleanroom and biocontainment capacity throughout the world. With a deployable rental fleet available, our Offsite Built, Process Ready facilities offer accelerated timelines and are provided with full integration of equipment, utilities, and services.

Client:
Pharmaceutical (Confidential)
Completion:
April 2020
Project Type:
Mobile
Application:
Biopharma
Location:
Indiana, USA