A 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 goal of Andelyn Biosciences is to support the advancement of novel gene therapies for rare genetic diseases by building commercial manufacturing capacity which is needed as more of these treatments are developed over the coming years,” Dennis Durbin, chief scientific officer of AWRI, said in a statement. “As a for-profit company, revenues generated by Andelyn Biosciences will allow us to reinvest back into the non-profit research mission at AWRI, supporting its commitment to advance best outcomes for children around the world.”
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.
AWRI is working with government programs to ensure it has enough qualified employees to staff the operation.
The hospital’s new facility will be coming online as a rush of new gene therapies will be coming to market and adequate manufacturing capacity is in doubt. It has been predicted that by 2025 there will be 800 gene and cell therapies in the biopharma pipeline and that the FDA will be approving between 10 and 20 a year.
Novartis biotech AveXis just opened another plant to produce Zolgensma, Novartis’ second gene therapy, while Pfizer is investing about $600 million in its gene therapy operation in North Carolina.
CDMOs like Japan’s Fujifilm Diosynth Biotechnologies, Thermo Fisher Scientific and Catalent are all expanding operations. And AWRI follows Harvard University as a research facility going commercial. Harvard is working with a consortium of contract manufacturers to build a $50 million facility dedicated to making cell therapies and viral vectors for gene therapies.