Pfizer Inc. (NYSE: PFE) announced today the opening of a new, state-of-the-art clinical manufacturing facility in Durham, NC. The facility expands Pfizer’s end-to-end capabilities in gene therapy and builds on the Company’s existing footprint in North Carolina, which includes more than 3,600 employees across sites in the state. The Durham facility is part of an $800 million investment over the past six years to build three scalable, state-of-the-art gene therapy manufacturing facilities to support Pfizer’s continued investment in gene therapy research, development, and manufacturing.
The Durham facility will be home to 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. The facility is expected to create more than 50 new jobs in the coming years, 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. “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 with approximately one to two first-in-patient clinical study starts anticipated each year.
Pfizer’s $800 million investment to build three scalable, state-of-the-art gene therapy manufacturing facilities includes 300,000 square feet of capacity, one of the largest in-house gene therapy manufacturing facilities, to support multiple gene therapy medicines. The three facilities demonstrate Pfizer’s deep commitment to rare disease patients and gene therapy. The Company has a total bioreactor manufacturing capacity of 22,000 liters, (2,000 liters / bioreactor x 11 bioreactors) using state-of-the art single-use manufacturing technology, scaled to serve the entire market for even the gene therapy indications requiring the administration of the highest doses of gene therapy vectors. These investments have given Pfizer one of the largest production capacities for gene therapy vectors globally. The single-use technology also allows more scalable expansion of manufacturing capacity over time.
The 85,500 square foot Durham facility is also an important part of Pfizer’s worldwide R&D network which includes locations in La Jolla, California; Boulder, Colorado; St Louis, Missouri; Pearl River, New York; Groton, Connecticut; and Cambridge and Andover, Massachusetts.
To learn more about Pfizer’s commitment to gene therapy, visit https://www.pfizer.com/science/research-development/gene-therapy/pioneering-breakthroughs