GMP Facility Core Laboratory
Versiti Blood Research Institute & Medical College of Wisconsin Vector Production Facility
The Versiti Blood Research Institute & Medical College of Wisconsin Vector Production Facility operates under the direction of Jeffrey Medin, PhD, MACC Fund Professor, Vice Chair of Research Innovation for the Department of Pediatrics, and Research Director of Pediatric Hematology/Oncology at the Medical College of Wisconsin (MCW).
The Vector Production Facility (VPF) provides gene transfer vectors and scientific expertise to investigators interested in conducing pre-clinical research. It is also developing the capacity to provide vectors and expertise to clinicians and scientists interested in acquiring/implementing clinical-grade vectors for early-phase gene therapy trials.
The facility’s dual-controlled access space includes independent ISO Class 7 cleanroom suites designed for the bioprocessing of plasmid DNA and the packaging of lentiviral vectors, as well as a quality assurance laboratory and a cold storage ward. The cleanroom environment is temperature- and humidity-monitored; airflow is HEPA-filtered and carefully controlled. All personnel inside the cleanrooms wear full sterile personal protective equipment, and all product manufacturing is conducted under aseptic conditions. The production suites are consistently monitored for sterility and are decontaminated between production runs. All of the equipment used in the manufacture of products is validated.
Likewise, critical production parameters are monitored in real-time and critical computer systems are compliant with 21 CFR part 11.
- Pre-clinical, research-grade lentivector design, construction and production
- Certification testing for both in-house and client research-grade preps (including functional titering of vectors and assessment of transduction efficiency)
- Clinical-grade cGMP lentiviral production and release testing (coming soon)
- cGMP plasmid production (coming soon)
- Quality assurance testing, including sterility, mycoplasma, endotoxin and more, on investigator-supplied laboratory samples (coming soon)
The Versiti Blood Research Institute & Medical College of Wisconsin Vector Production Facility is happy to serve not only internal investigators from the Milwaukee Regional Medical Center, but external investigators as well.