Montgomery County pharmaceutical-services firm is undertaking a $65 million expansion

Almac Group, a Northern Ireland pharmaceutical services company with North American headquarters and major operations in Souderton, is undertaking a $65 million expansion that is expected to add 200 jobs at the Montgomery County location, where the company already employs 1,000, company officials said Thursday.

The 100,000-square-foot expansion will help Almac, whose biggest division in Souderton helps pharmaceutical manufacturers conduct clinical trials, meet increasing demand from biopharmaceutical companies. Biopharmaceuticals must be kept cold, often well below freezing.

In its clinical supply business, Almac packages, labels, stores, and distributes medicines and other treatments that are being tested on humans to see if they are effective or, in some cases, better than current treatments. The Souderton facility played a key part in getting the Pfizer-BioNTech COVID-19 vaccine through clinical trials in 2020.

“The growth in biopharmaceuticals, vaccines, monoclonal antibodies, and the like has just exploded, particularly over the last 10 years,” said Mark Rohlfing, an Almac vice president of operations for Almac’s clinical supply division. “A lot them are protein-based, so they degrade if you take them out of refrigeration.”

When Almac’s Souderton facility opened in 2010, the company had one small cold room on the production floor — “just in case we might have to do a refrigerated job,” Rohlfing said. “Today we have five rooms out on the floor that are booked solid through the rest of the year, and we will be up to 12 rooms after the end of the expansion.”

Sometimes Almac employees work in rooms that are kept at minus 4 degrees Fahrenheit, Rohlfing said.

The expansion, expected to be completed in 2025, will triple the number of investigation-stage treatments Almac will be able to store and process. The company, which is owned by an Irish foundation, reported revenue for the year ended Sept. 30, 2021, of 735 million British pounds. At current exchange rates, that amounts to $885 million.

Almac employs 6,500 globally. Locally, Almac also has operations in Audubon and Lansdale with a total of about 700 employees. It also has a facility in Durham, N.C.

Another trend Almac is adapting to is just-in-time production of treatment kits for drug trials. The cost of new drugs — sometimes as much at $50,000 for a single vial — makes it too expensive to prepare a large number of kits and then wait for patients to join the trial.

“You want to minimize the amount of waste of that very expensive medicine,” said Richard Segiel Jr., vice president of business development for Almac clinical services. Plus, some of the new medicines are individualized for specific patients. That’s especially true of cell and gene therapies, which are a new frontier in medicine.

The Almac project adds to a string of recent Philadelphia-area investments in manufacturing and services related to biopharmaceuticals.

Late last year, Purolite opened a new factory in King of Prussia that makes tiny resin beads that are used in water purification and in the production of biopharmaceuticals. Spark Therapeutics, a Philadelphia gene therapy company owned by Roche, last month broke ground on a $575 million its Gene Therapy Innovation Center in University City.

On a smaller scale, West Pharmaceutical Services Inc., an Exton company that makes products used to administer injectable medicines, this month expanded into a new research and development lab in Radnor that is more than twice the size of the older Exton facility.

Almac’s major competitors — Fisher Clinical Services, Catalent, and PCI Pharmaceutical Services — also have major operations in Philadelphia or nearby, thanks to the region’s long history in the pharmaceutical industry.

Almac finds many of its new customers in other biopharmaceutical hotbeds, like Boston, North Carolina, San Francisco, and San Diego, but the Philadelphia region is still running strong, according to Segiel.

“We still see a lot of new customers in this region, right in our backyard,” he said.