GSK opens $120m single-use drug substance plant in PA

Equipped with disposable bioreactors up to 2,000 L, the plant in Upper Merion is ready to begin practice runs for GSK’s inducible T cell co-stimulatory (ICOS) receptor-agonist candidate.

The site in Upper Merion, Pennsylvania has been a major source of manufacturing for GlaxoSmithKline (GSK) for over 20 years. With the opening of the $120 million (€110 million) ‘next-generation’ facility, the firm says it has created a “technologically-advanced manufacturing hub that offers the flexibility and speed necessary when making today’s complex specialty medicines.”

The plant is equipped with disposable bioprocessing equipment, spokesperson Courtney Dysart told Bioprocess Insider, making it stand out from the stainless-steel heavy facilities that make up the bulk of GSK’s biomanufacturing network.

GSK’s site in Upper Merion, PA. Image c/o Google

“The facility uses 2,000 L bioreactors, designed for smaller batches of bulk drug substance manufacturing,” she said, adding the single-use systems “will support assets we have in our specialty pipeline, particularly in the areas of oncology and immunology.”

GSK’s inducible T cell co-stimulatory (ICOS) receptor-agonist oncology candidate, GSK3359609, in clinical trials both on its own and in combination with pembrolizumab, will be the first potential medicine manufactured in this new facility, we were told.

“We will begin ‘practice runs’ for ICOS next week. This process is an important step for GSK to commission the facility in line with regulatory requirements and secure appropriate licenses from regulators such as FDA.”

No new jobs have been created with the new plant, but some of the 350 employed at the Upper Merion site will be reassigned or retrained to support the new facility.

“GSK has a strong presence in Upper Merion, with biopharmaceutical manufacturing, research and development and a technical center of excellence co-located on campus. Upper Merion is also near our US R&D hub in Upper Providence, PA and our US Pharmaceuticals headquarters in Philadelphia. These, along with existing and available footprint, were key drivers in the decision to build.”