BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, today announced in partnership with Germfree the opening of its new cleanroom manufacturing space in Winchester, Virginia. The cleanroom leverages design and solutions from Germfree to further establish BioIVT as a provider of uncompromised access to critical GMP-compliant ancillary materials. BioIVT's GMP-compliant cell and gene therapy supporting raw materials, including Human AB serum, will gain immediate benefits with the integration of industry leading cleanroom processes.
The new cleanroom manufacturing space is purpose built to support excipient and ancillary material bio processing workflows. Ensuring the highest level of quality and regulatory compliance, the cleanroom boasts the following features:
- Qualified in accordance with FDA requirements
- ISO 7
- FDA-cGMP, ISO, ISE, CDC-BMBL and ASTM tested
- HVAC controls (BMS/EMS) systems
- HEPA filtration
