USA – Pfizer has announced the opening of a US$68.5 million gene therapy manufacturing facility in Durham, North Carolina, as part of a multi-yearUS$800 million plan to outfit its next-generation therapeutics business.

The 85,500-square-foot facility will house Pfizer’s BioTherapeutics Pharmaceutical Sciences Group, which is in charge of the manufacturing and analytical release of clinical supplies for Pfizer’s gene therapy and biologics portfolio, according to the drugmaker.

According to Pfizer, the site will create 50 new jobs in the area, with approximately 40 employees expected to relocate from an existing site in nearby Chapel Hill.

“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, Pfizer’s VP of BioTherapeutics Pharmaceutical Sciences, in a statement.

The Covid-19 pandemic has been extremely profitable for Pfizer, and the behemoth pharmaceutical company is using that leverage to advance its portfolio as a whole. Pfizer’s emerging gene therapy business will now have more breathing room as it expands in the coming years.

This investment is part of a US$800 million investment made by Pfizer over the last six years to establish a strong supply chain for its burgeoning gene therapy business, according to the company.

In total, the new network of facilities will cover 300,000 square feet and have a capacity of 22,000 liters of single-use manufacturing. According to Pfizer, the massive investment gives it a competitive advantage in viral vector production.

The drugmaker, flush with cash from the sale of its Covid-19 vaccine, has made gene therapy a top priority in recent years, and it will be a focal point of its future R&D strategy centered on next-generation drugs.

Pfizer’s three gene therapy sites in North Carolina each serve a unique purpose. Durham is for clinical manufacturing in phases one and two. It’s a full-service facility that includes drug substance and product manufacturing and filling, as well as analytical and microbiology labs.

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

The company’s use of single-use technology allows for scalable manufacturing expansion over time.

Pfizer’s gene therapy portfolio includes treatments for hemophilia A, hemophilia B, and Duchenne muscular dystrophy that are in the late stages of development (DMD).

Furthermore, the company has 12 preclinical programs that are researching treatments for cardiology, endocrine, hematology, metabolic, and neurology diseases. Each year, the company hopes to begin one to two clinical trials in the field.

While many other large pharmaceutical companies rely on contract manufacturing, Pfizer, along with Novartis and Roche, is one of the few that is developing its own gene therapy manufacturing network.

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