Microbiome Research Modular Cleanroom
This BSL 2+ cGMP Modular Biocontainment Cleanroom Facility is made up of five (5) prefabricated modules (2,000 ft2 / 184 m2 gross area) and is housed within a renovated warehouse structure. The cleanroom is designed to comply with FDA and EU cGMP standards and utilizes a unidirectional process flow. This facility provides Arranta Bio with a Phase I and Phase II clinical manufacturing facility for Microbia by microbial fermentation.Germfree’s bioGO® Modular & Podular Cleanrooms and Biocontainment Suites are available in standard and custom configurations to meet a wide variety of cGMP development and manufacturing 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 Modular (multi-building/level structure, HVAC/MEP on modules or adjacent) and Podular (single-building, HVAC/MEP inside building) units deliver critical cleanroom and biocontainment capacity throughout the world. Our Offsite Built, Process Ready facilities offer accelerated timelines versus traditional construction methods and are provided with full integration of equipment, utilities, and services.