As part of $800M investment, Pfizer opens gene therapy facility in NC for early-stage production

Pfizer is betting big on gene therapy development and manufacturing. And to that end, it is centralizing its operations in—where else—North Carolina.

These days in the biopharma industry, it seems every other new facility or upgraded site is in the Tar Heel State.

On Wednesday, Pfizer opened a new complex in Durham. It's an 85,000 square foot site which is part of an overall $800 million investment in three gene therapy facilities in the state.

The plant replaces and updates a smaller site in nearby Chapel Hill. Fifty employees from that plant will move to Durham, soon to be joined by 40 new hires. The net effect will be a quadrupling of clinical manufacturing capacity.

“At (Chapel Hill) we manufacture one product at a time,” Beth Ann Bort, the site lead and analytical R&D director, said in an interview. “This new facility allows us the opportunity to work on multiple projects at the same time. We have multiple drug substance suites. We have separate drug product suites. It allows us to manage a broader portfolio.”

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Each of Pfizer’s three gene therapy sites in North Carolina serves a different function. Durham is for phase one and two clinical manufacturing. It’s a complete site with drug substance and product manufacturing and filling, along with analytical and microbiology labs.

Another facility 50 miles to the south in Sanford is for late-stage and commercial development, while the company's Morrisville site, 10 miles south of Durham, is for pre-clinical process development and regulatory toxicology manufacturing.

The single-use technology the company is incorporating allows scalable expansion of manufacturing over time.

“With the growth in our portfolio, we needed a significant expansion, so this allows us to do that,” Paul Mensah, Pfizer’s VP of bio therapeutics and pharmaceutical sciences, said. “In North Carolina we have the capability for end-to-end development. We have process development. We have clinical manufacturing, and we have commercial manufacturing.”

Pfizer’s gene therapy portfolio includes late-stage treatments for hemophilia A, hemophilia B and Duchenne muscular dystrophy (DMD). In addition, the company has 12 preclinical programs investigating treatments in cardiology, endocrine, hematology, metabolic and neurology diseases. The company hopes to start 1 to 2 clinical trials each year in the field.

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While many other big pharmaceutical companies rely on contract manufacturing, Pfizer is one of the few—along with Novartis and Roche—that are building their own gene therapy manufacturing network. 

“With gene therapy we have the potential to address diseases that have never been addressed before. It’s an area where we basically have committed to be all in,” Mensah said. “We think we have the expertise, the talent and now the capacity and facilities to really win in this space. Pfizer is really committed here. We think it is a technology that’s very transformational.”