- Thermo Fisher Scientific has opened a $90 million, 50,000-square-foot viral vector manufacturing facility in Lexington, Massachusetts, the company said Wednesday.
- The contract development and manufacturing organization expects to create more than 200 jobs at the site, which will support development, testing and manufacturing for viral vectors, the inactivated viruses used to deliver gene therapies.
- The investment will help address a "bottleneck" in manufacturing viral vectors, Thermo Fisher said in a Dec. 4 statement.
The new facility builds on Thermo Fisher's larger push into gene therapy manufacturing. Earlier this year, the company paid $1.7 billion for viral vector contract manufacturer Brammer Bio.
"The demand for new gene therapies has outpaced capacity, and we're in a unique position to partner with our customers to help them accelerate development and production of medicines that will ultimately benefit patients suffering from rare diseases," Michel Lagarde, the company's executive vice president, said in the statement.
Rivals in the CDMO space are also pouring money into production of the highly complex treatments. Last month, Fujifilm announced a $120 million investment in gene therapy. And Catalent this year paid $1.2 billion for gene therapy manufacturer Paragon Bioservices.
At the same time, some drugmakers are deciding they don't want to rely on CDMOs and are making their own investments into facilities.
A Reuters analysis found that 11 drugmakers have earmarked a total of $2 billion for gene therapy manufacturing since 2018. At the top of the list were Pfizer, with a $600 million investment plan, and Novartis, which intends to spend $500 million, Reuters reported.
When Japanese drugmaker Astellas this week announced its $3 billion deal to buy the San Francisco-based biotech Audentes Therapeutics, the biotech's manufacturing capability was a key consideration. Audentes has a sizable plant that can support clinical and commercial gene therapy production.
The Food and Drug Administration, meanwhile, is working to keep up. The agency is finishing up guidelines for gene therapy production. And the head of the FDA's biologics division earlier this year told BioPharma Dive that manufacturing is his top concern about gene therapy.
"If we can help see cost of goods and ability to manufacture reproducibly improve, I think that'll be a big thing,” Peter Marks, head of the FDA's Center for Biologics Evaluation and Research, said in an interview published in June. “That's something we're working on, but something that keeps me up at night."