GMP Vector Production | Translational Cores

GMP Vector Production

The Vector Production Facility manufactures lentiviral and retroviral vectors in a cleanroom facility that is compliant with FDA’s current Good Manufacturing Practices (cGMP) for the manufacturing of viral vectors in support of early phase clinical trials. The facility has been in operation since 2005.

The cleanroom space consists of approximately 1,600 square foot of controlled-access space with three (3) independent ISO Class 7 cleanroom suites equipped with biosafety cabinets for aseptic processing. Support areas include, a Gown and De-Gown room, a Materials Airlock, pre-and post-production corridors, and a support room for closed processing.

Services offered include small to mid-scale GMP-like manufacture and large-scale GMP Lentiviral and Retroviral vector products. We support certification and stability studies for viral vectors manufactured in-house or externally.

All critical facilities and equipment used in GMP manufacturing have been validated to meet Phase I/II drug product requirements and all instruments have been calibrated to NIST standards. Critical computer systems are compliant with 21 CFR Part 11 suitable for Phase I/II.  Aseptic processes have been validated to meet the requirements set forth in the Guidance for Industry, Sterile Drug Products Produced by Aseptic processing and are compliant with 21 CFR Parts 210 and 211.

A Type V Master File (MF-BB) is on file with FDA/CBER. A letter of cross reference to the DMF is available upon request. VPF staff have experience in providing investigators support in development of relevant CMC (Chemistry Manufacturing and Control) sections for vector production for both INDs and IMPDs.