At its site in Sanford, US, Pfizer manufactures investigational gene therapies for the treatment of rare diseases, as well as components for its vaccine portfolio, including Prevnar 13, a pneumonia vaccine with nearly $6bn (€5.4bn) sales in 2018. Pfizer began working on the site's expansion in January 2019 and expects to have it completed in early 2022, a spokesperson told us.
The $500m (€450m) investment follows Pfizer’s $100m investment to establish the Sanford site in 2017. Upon completion of the expansion, the facility is expected to further support Pfizer’s gene therapy R&D activity at its North Carolina sites in Chapel Hill and Kit Creek.
Additionally, with the expanded footprint in the area, Pfizer announced plans to advance its clinical and commercial scale production capabilities for one-time gene therapies that use recombinant adeno-associated virus (rAAV) vectors.
A spokesperson for Pfizer also told us that the expanded site would cover approximately 100,000 square feet and will include eight single-use bioreactors of 2,000L each. Following the expansion, the facility will have the ability to "run multiple products concurrently," the spokesperson said.
Mike McDermott, president of Pfizer Global Supply, said in a statement that the investment is part of the company’s “overall plan to invest approximately $5bn in US-based capital projects over the next several years.”
The expansion is projected to add approximately 300 new employees to the 650 who are already employed at the company’s site in Sanford. Through its existing facilities in North Carolina, Pfizer employs approximately 3,600 people in the state.
The small scale facilities in Kit Creek and Chapel Hill have a capacity of 250L bioreactors each, which have been utilized to develop the process for use in larger scale manufacturing.
Competing in the gene therapy race
Pfizer has made significant investments to establish its position in the emerging gene therapy R&D space, such as with the acquisition of Vivet, an AAV gene therapy developer, for over $600m, earlier this year.
The investment in the market is rising, especially after Novartis received the green light to market its gene therapy Zolgensma (onasemnogene abeparvovec), at the price of $2.1m per patient – becoming the most expensive commercially available drug.
Bolstering DMD treatment development
The Sandford facility supplies the clinical trial materials for PF-06939926, the company’s Duchenne muscular dystrophy (DMD) gene therapy candidate, which is soon to enter Phase III trials.
Mikael Dolsten, president of worldwide research and development at Pfizer, spoke about the progress of the product’s development during a conference call earlier this month.
“Our manufacturing including large-scale 2,000-liter bioprocessors are on track,” Dolsten said, adding that the company aims to continue the product development with a pivotal study in 2020, after having seen ‘sufficiently encouraging’ clinical data.
The news about the Sanford facility expansion came only two days after the FDA rejected the new drug application for Golodirsen (SRP-4053), a DMD treatment candidate rival being developed by Sarepta Therapeutics.