CDMOs are building cell and viral vector manufacturing facilities left and right, but Harvard says it just isn’t enough, at least to serve the Boston biotech hub. That is why a host of public and private players is working on a $50 million clinical supply manufacturing facility.
The facility will help researchers at biotechs, universities and hospitals avoid production bottlenecks that can delay clinical material for more than a year, Harvard said in announcing the project today.
“Currently, major obstacles to getting new treatments into the clinic revolve around production, specifically the pressure placed on highly skilled contract manufacturers to deliver to labs around the region customized, high-quality cells and viral vectors that meet regulatory standards. Because of the backlog, scientists may need to wait as long as 18 months for the essential products they need to carry out their research,” Harvard said.
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The not-for-profit facility, to be built in the Greater Boston area, will have eight clean rooms and offer “preferred access … at favorable pricing” the group says.
Board members will come from Fujifilm Diosynth Biotechnologies, GE Healthcare Life Sciences and Alexandria Real Estate Equities as well as Harvard and the Massachusetts Institute of Technology. Contributing members include the state, a list of hospitals and MilliporeSigma.
In addition to manufacturing, the group says the facility will provide training and collaboration with top researchers.
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This project comes even as drugmakers are getting gene therapies approved and contractors are moving fast to buy or boost capacity to serve the growing viral vector and gene therapy fields. Earlier this year, Catalent dropped $1.2 billion to grab viral vector and gene therapy manufacturer Paragon Bioservices, and Thermo Fisher shelled out $1.7 billion to get viral vector producer Brammer Bio. Thermo Fisher now has a facility in Massachusetts, along with others, while Catalent got one in Baltimore. Other contractors are adding or expanding facilities in the U.S., Europe and Asia.