GMP Facility Core Laboratory

The GMP laboratory provides gene transfer vectors and scientific expertise to investigators conducting pre-clinical research.

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).


 

Contact Information

Monty McKillop, PhD
Manager
mmckillop@mcw.edu
414-955-4117

Accreditations and Licenses

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.

Services Include

  • 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.

 
Accreditations & Licenses
Versiti and its affiliates hold numerous accreditations and licenses, listed here for each Versiti affiliate.
 
Scientific Programs
Scientific research and training are important parts of Versiti’s mission. Our research programs involve basic and clinical scientists at Versiti Blood Research Institute.
 
Core Facilities & Services
Versiti Blood Research Institute provides a number of core facilities and services available to investigators, including the latest technology and equipment.
 
Versiti Blood Research Institute
Versiti Blood Research Institute investigators study blood disorders like hemophilia, blood cancers like leukemia, and other blood diseases.