Pfizer will expand its manufacturing of gene therapies in North Carolina, where the pharma giant joined Gov. Roy Cooper in announcing plans for a $500 million facility expansion in Sanford that is expected to add 300 jobs to its local workforce of 650.

The planned expansion—which will grow its Sanford workforce by nearly 50%—comes three years to the month that Pfizer expanded into gene therapy by acquiring Bamboo Therapeutics for up to $645 million. The following year, Pfizer raised its proverbial bet on gene therapy with a $100 million, 40-job expansion to the company’s vaccine manufacturing plant in Sanford.

“Our purpose is to deliver breakthroughs that change patients’ lives. And expanding these end-to-end capabilities that we have here in Sanford in gene therapy is exactly how we are going to make this happen,” Angela Hwang, group president, Pfizer Biopharmaceuticals Group, said yesterday at a ceremony at the Sanford facility, according to a video of the event posted by WRAL TechWire.

Hwang and other Pfizer executives joined Cooper at the ceremony, which also marked the completion of the first phase of the expansion.

Pfizer said the expansion will advance its ability to produce potentially one-time gene therapies that use custom-made recombinant adeno-associated virus (rAAV) vectors—thus strengthening its ability to supply both clinical- and commercial-scale quantities of the treatments.

Positive clinical results

Gene therapy has been a growing priority at Pfizer. Last month, the company joined Sangamo Therapeutics in trumpeting positive updated results from the Phase I/II Alta study (NCT03061201) assessing SB-525, a gene therapy candidate indicated for severe hemophilia A that recently received the FDA’s regenerative medicine advanced therapy (RMAT) designation.

And in June, Pfizer presented positive initial Phase Ib clinical data on another gene therapy candidate, PF-06939926, a potential treatment for Duchenne muscular dystrophy. Data from the study will inform dose selection and the design of a Phase III trial planned to start in the first half of 2020, Pfizer said at the time.

Beyond clinical trials, Pfizer is seeking to support early-career professionals in gene therapy by contributing $4 million into a multi-year academic fellowship program designed to support postdoctoral research fellowships in the field at university laboratories across North Carolina. Established in 2017, the fellowship program is designed to fund a total of 18 fellows spread across three classes, with the first six awarded in fall 2017. The program is managed by the state-funded North Carolina Biotechnology Center.

In addition to producing gene therapies, Pfizer’s Sanford facility also manufactures components for the company’s vaccine portfolio, including Prevnar 13 and several investigational vaccines. The Sanford site is one of Pfizer’s 49 manufacturing sites worldwide.

Sanford is one of three North Carolina sites where Pfizer carries out gene therapy R&D. In Kit Creek, NC, Pfizer researchers have worked from 2 L flasks up to 250 L bioreactors to develop a process that the company expects to use eventually in larger-scale manufacturing. That process has been optimized at Pfizer’s Chapel Hill, NC, facility, where staffers have implemented quality control measures included in GMP standards while working at a 250 L scale.

“Pfizer’s focus on these processes, combined with its existing and new investment here in Sanford, is designed to result in a high-quality, efficient supply of gene therapies at clinical and commercial scale,” said Mike McDermott,pPresident, Pfizer Global Supply. “This investment will further strengthen Pfizer’s leadership in gene therapy manufacturing technologies, which will help us develop novel methods to deliver transformative treatments to patients.”

A growing industry

Pfizer employs more than 3,600 people in North Carolina—and is among anchors of the state’s growing gene therapy industry. Already this year:

  • Asklepios BioPharmaceutical (AskBio) said in April that it received a $225 million investment from TPG Capital and Vida Ventures. As part of the deal, AskBio’s founders and board members agreed to co-invest $10 million.
  • AveXis, a Novartis Company, said in February it will expand the Durham County, NC, site it began building last year, creating 400 jobs by the time it becomes operational in 2020.
  • bluebird bio in March opened its first wholly-owned manufacturing facility in Durham, NC, with approximately 70 employees expected to be based there by year’s end.
  • Cellectis said in March it will create its first North American manufacturing site in Raleigh, NC, a $70 million investment projected to create 200 jobs.

A significant portion of North Carolina’s gene therapy activity occurs within the Raleigh/Durham region that includes Research Triangle park—and which was ranked No. 8 in the most recent annual GEN A-List of Top 10 U.S. Biopharma Clusters, published in September 2018. An updated list will be published this fall.

“Today we mark another boost to our state and we are proud of the people conducting life-saving research in Sanford,” Cooper stated yesterday. “North Carolina is a leader in life sciences in part because of our long-standing partnership with Pfizer.”

Beyond gene therapy, the Sanford expansion is part of a broader plan by the pharma giant to invest approximately $5 billion in U.S. manufacturing operations over the next five years. Pfizer’s U.S. manufacturing activities employ more than 10,000 people, McDermott said.

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