GMP Facility Core Laboratory
The GMP laboratory provides gene transfer vectors and scientific expertise to investigators conducting pre-clinical research.
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).
Monty McKillop, PhD
Manager
mmckillop@mcw.edu
414-955-4117
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.
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.