The Research Institute at Nationwide Children’s Hospital is the home to a current Good Manufacturing Practices (cGMP) Clinical Manufacturing Faculty that operates according to FDA cGMP Guidelines to ensure the safety of manufactured biologic products.
The CMF space is 9000-sq ft space. It consists of a 7500-sq ft. clean room suite with ISO Class 5/7/8 spaces and 1500-sq ft. of quality control lab and research production 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.
The Clinical Manufacturing Facility at Nationwide Children’s Hospital is a Leading cGMP production facility dedicated to advancing the field of Gene and Cellular Therapy.
Our Mission is to use our knowledge, resources, technology, and experience in the field of translational and regulatory science, in collaboration with our clients, to develop new, safe, and effective long term treatments for diseases. There is no disease too rare and no challenge too difficult as we strive to make a difference with every product and to leave hope with every patient and family.