new commercial-scale gene therapy manufacturing facility is being planned, but not by a biotech or even a CDMO. This one will be built by a hospital in Columbus, Ohio. Nationwide Children’s Hospital’s Abigail Wexner Research Institute (AWRI) expects to have a commercial gene therapy manufacturing facility up and running in 2023. AWRI, which is deeply involved in gene therapy research, already has an FDA-approved clinical-scale gene therapy operation. AWRI added to the surprise by announcing the new operation, to be called Andelyn Biosciences, will be a for-profit enterprise. The institute currently operates a 9,000-square-foot clinical supply facility for gene therapy. It consists of a 7,500-square-foot clean room suite with ISO Class 5/7/8 spaces and 1,500 square feet of quality control lab and research production space. The facility is approved to produce early-stage clinical material for investigational drugs, but the institute says that this summer it expects it to be approved to start manufacturing phase 3 products while the commercial facility is built.
For further information, see FiercePharma (https://www.fiercepharma.com/manufacturing/research-hospital-jumping-into-commercial-production-gene-therapies?mkt_tok=eyJpIjoiWTJWa1kyUm1NbVJrTkRGbCIsInQiOiIyT1N3WmFPRVRZbWlhOGRjK0hpaitNWTRGSWR3TFZPNVFaN3ZSa1pXT0Zrd3VQeFl3Tkp0Y251VEdjb1ptRmtLR2xid2lYTituMjlUZ2p0dzNtQWF5ck1ZamlRNmdKcWRDWVEyNUJYcXpkOUpXdkNucHVcL1pQTXpWWlNQZG1iSVoifQ%3D%3D&mrkid=75529467)
