New year, new gene therapy plants from Pfizer and Expression

Christmas came early for Pfizer and Expression Therapeutics, which cut the ribbons on viral vector manufacturing plants in North Carolina and Ohio, respectively.

Pfizer’s gene therapy division celebrated the new year with an expanded manufacturing footprint, having opened the first of three facilities at its site in Durham, North Carolina on December 15.

The 85,500 square-foot plant will support clinical manufacturing of Pfizer’s gene therapy pipeline and represents an investment of $68.5 million by the firm. The facility will create more than 50 jobs in addition to approximately 40 employees who will relocate from Pfizer’s nearby Chapel Hill site.

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The facility is part of an $800 million capital expenditure plan by the Big Pharma firm intended to build what it describes as “one of the largest production capacities for gene therapy vectors globally.”

The planned 300,000 square feet of capacity across the three scalable plants aims to support multiple gene therapy medicines within Pfizer’s pipeline, including three late-stage clinical programs for hemophilia A, hemophilia B, and Duchenne muscular dystrophy (DMD), and 12 preclinical programs for rare cardiology, endocrine, hematology, metabolic and neurology diseases.

According to the firm, it will soon boast a total bioreactor manufacturing capacity of 22,000 liters through 11 single-use 2,000 L systems dedicated to viral vector production.

Expression in Ohio

Meanwhile, approximately 400km northwest, clinical cell and gene therapy firm Expression therapeutics is celebrating the opening of its first viral vector manufacturing facility.

The 43,000 square-foot plant in Cincinnati, Ohio, run by manufacturing subsidiary Expression Manufacturing LLC, opened on December 17 and will provide early phase and commercial scale manufacturing of GMP cell and viral vector products for both its own product pipeline and as a CDMO for other gene therapy developers.

“”With GMP vector manufacturing backlogs typically exceeding 18 months, we wanted to bring in-house manufacturing capabilities online and provide CDMO services to commercial clients as soon as possible,” said Expression Manufacturing president Bill Swaney.

“The opening of the facility allows us to immediately support our internal therapeutic pipeline in hematology and oncology. In fact, we just completed three full-scale engineering runs for our lead cell therapy product ET206, which is intended to treat Neuroblastoma.”