Catalent was approved by the U.S. FDA to produce commercial drug substance intermediate for AveXis’ spinal muscular atrophy (SMA) gene therapy at its manufacturing facility in Harmans, MD.
The approval follows an FDA inspection of the Harmans commercial-scale gene therapy manufacturing center in June. Under Catalent’s partnership with AveXis, a Novartis company, a dedicated suite space has been prepared at the Harmans facility for the commercial manufacture of this adeno-associated virus (AAV) gene therapy.
“This is a significant milestone for Catalent and the gene therapy industry as a whole. Catalent is proud to be the first contract development and manufacturing organization to be approved for commercial gene therapy production,” commented Manja Boerman, Ph.D., President of Catalent Cell & Gene Therapy. “This approval allows us to leverage our now-licensed, state-of-the-art GMP commercial manufacturing facility, and our deep AAV expertise, to support AveXis as it delivers a life-changing treatment for patients.”
“Given the complexity and length of time required to make gene therapies, manufacturing is critically important,” said Dannielle Appelhans, Chief Technical Officer for AveXis. “This approval further complements our internal manufacturing capacity and, over time, will allow us to increase supply to meet growing patient needs.”
Catalent’s Harmans commercial manufacturing facility, located near BWI airport, is equipped with single-use technology, and houses over 200,000 sq.-ft. of late-stage clinical and commercial-stage gene therapy production. The facility is one of Catalent’s five gene therapy facilities in Maryland providing clinical through commercial scale services, and houses multiple CGMP manufacturing suites, including fill/finish, central services and testing labs, warehousing, and supply chain capabilities.