Pfizer Opens Gene Therapy Clinical Manufacturing Facility

Pfizer opened a new clinical manufacturing facility in Durham, NC that expands the company’s end-to-end capabilities in gene therapy and builds on its existing footprint in the region, the company announced in a Dec. 15, 2021 press release. A $68.5 million investment in the Durham facility is part of an $800 million investment over the past six years to build three scalable gene therapy manufacturing facilities to support Pfizer’s continued investment in gene therapy research, development, and manufacturing.

The Durham facility will house Pfizer’s BioTherapeutics Pharmaceutical Sciences Group, which is responsible for the manufacturing and analytical release of clinical supplies for Pfizer’s gene therapy and biologics portfolio. According to the press release, more than 50 new jobs will be created, in addition to the approximately 40 employees who will relocate from Pfizer’s Chapel Hill, NC site.

“Gene therapy represents the next wave of innovation for patients living with rare diseases, for whom there are limited treatment options currently available,” said Paul Mensah, vice- president, BioTherapeutics Pharmaceutical Sciences at Pfizer, in the press release. “Today represents the next step in strengthening Pfizer’s in-house gene therapy capabilities and underscores the unique ability, expertise, and resources we have to guide gene therapy through the entire development and manufacturing process and deliver this potentially life-changing technology to patients.” 

Pfizer’s current gene therapy portfolio includes three late-stage clinical programs for hemophilia A, hemophilia B, and Duchenne muscular dystrophy (DMD), as well as 12 preclinical programs investigating potential treatments for rare cardiology, endocrine, hematology, metabolic, and neurology diseases. The company anticipates starting one or two first-in-patient clinical study each year.

The three gene therapy manufacturing facilities together include 300,000-ft2 of capacity, with 11 bioreactors that are each 2000-L. These investments have given Pfizer one of the largest production capacities for gene therapy vectors globally, according to the press release. The facilities use single-use technology, which allows more scalable expansion of manufacturing capacity over time.

Source: Pfizer