Viral Vector Core/Clinical Manufacturing Facility

Viral Vector Core

The Viral Vector Core (VVC) supplies recombinant adeno-associated virus (rAAV) vectors of superior quality to individual research laboratories. The VVC is a full-service facility assisting with the design of AAV expression cassettes for optimum levels of gene expression in target tissues that enable investigators to transition seamlessly from the bench to the bedside. The VVC now supports the production of eight different recombinant AAV vector serotypes (AAV1, AAV2, AAV2NHB (non-heparin binding), AAV5, AAV6, AAV8, AAV9 and AAVrh74) at a variety of scales ranging from small (2E+12 VPs) to custom large-scale productions (>1E+14 VPs) to support large animal and preclinical toxicology studies. All research grade vectors are purified to remove empty particles and have passed rigorous quality control standards.

Clinical Manufacturing Facility

In 2009, Nationwide Children’s Hospital established a current Good Manufacturing Practice (cGMP) Clinical Manufacturing Facility (CMF). The CMF specializes in the production of recombinant adeno-associated virus (rAAV) vectors for use by faculty at Nationwide Children's Hospital, The Ohio State University Medical Center and external collaborators. The primary focus of the CMF is to provide researchers with the highest quality gene transfer vectors to support early phase clinical trials. The CMF consists of a 9,000-sq ft. clean room suite with ISO Class 5/7/8 spaces. The biological drug substances are manufactured according to the FDA Guidance for Industry cGMP for Phase I Investigational Drugs, to ensure product safety, identity, purity and strength.

Clinical Manufacturing Facility