The Viral Vector Core supplies recombinant adeno-associated virus (rAAV) vectors of superior quality to individual research laboratories. The Core 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 core now supports production of eight different recombinant AAV vector serotypes (AAV1, AAV2, AAV2NHB (non-heparin binding), AAV5, AAV6, AAV8, AAV9 & AAVrh74) at a variety of scales ranging from small (2E+12VPs) to custom large-scale productions (>1E+14VPs) 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.
In 2009, NCH established a current Good Manufacturing Practice (cGMP) Production Facility, also known as the Clinical Manufacturing Facility (CMF). The CMF specializes in the production of recombinant Adeno-Associated viral vectors (rAAV) 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 1,200-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.
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