Almac Sciences, a member of the Almac Group, said today it has expanded its suite of analytical solutions to include biologics testing solutions.

The company said its services will now include, in part, GMP lot release and stability services to support clients’ drug substance and drug product programs for both novel biologics and biosimilars. New services will also include fit-for-purpose analytical method development/phase-appropriate method validation; as well as raw material testing for microbial and mammalian expression systems that comply with pharmacopeial requirements and clients’ specifications.

“The move into biologics is a further extension of our analytical testing capabilities,” John Robson, PhD, vice president, analytical operations at Almac Sciences, told GEN. “Any previous requirements for biologics testing were subcontracted to a number of different CROs depending on the project and the specific requirements of the assay.”

Almac is making an initial investment of over €2 million ($2.3 million) this year through 2021 on equipment and infrastructure within the current facility.

“We plan further expenditure in facilities and equipment as the business grows,” Robson said.

To carry out the additional biologics testing, Robson said, Almac plans to add 10 additional scientists to its current global analytical team. The company has also appointed two executives within the past six months in order to provide additional leadership and site management that ensures its ability to continue carrying out expanded biologics testing.

Simon Cocks, PhD, has been appointed as Athlone site manager. A 25-year industry veteran, Cocks previously managed multifunctional/multisite technical and support teams for previous CRO/CDMO and pharmaceutical employers. He is a chartered chemist and a Fellow of the Royal Society of Chemistry.

Pavan Kumar Kunala has been recruited as biopharma lab manager, also based at Almac’s Athlone facility.  Pavan previously held positions at Intas Biopharmaceuticals and Pfizer, where he was responsible for leading a team of scientists to support analytical method development, validation, and overall CMC strategy for the advancement of early, late, and commercial biologics.

Further growth in headcount will be in line with demand, Almac added.

“Best-in-Class” commitment

“The launch of this service offering furthermore demonstrates Almac’s commitment to offering a best-in-class service to our global client base and in advancing human health,” Robson said. “We are confident the addition of biologics testing solutions will continue to strengthen our competitive position in the marketplace.”

Almac Sciences said the expansion of biologics analytical testing solutions complemented the company’s established range of analytical services, which are offered from Athlone, Ireland, as well as from its global headquarters campus in Craigavon, Northern Ireland, and its U.S. headquarters in Souderton, PA.

The three sites now employ more than 150 scientists.

In April 2019, Almac Group announced plans to expand its global analytical services capabilities, as well as expand its Athlone laboratory space to support microbiology and GMP analysis of small and large molecules, citing ongoing and increased demand. The company said at the time that it would double its Athlone workforce by creating up to 40 highly-skilled new jobs over two years.

Almac Sciences is a provider of integrated services from development to commercial scale of advanced intermediates and active pharmaceutical ingredients (APIs), as well as services for small molecules and peptides.

Analytical services are among offerings of Almac Group, a privately-held CDMO that employs more than 5,600 people across 18 facilities including Europe, the United States, and Asia. In June, Almac Group reported 2018–19 pre-tax profits of £47.6 million ($60.6 million), up nearly 73% from £27.6 million ($35.1 million) the previous fiscal year, on revenues that rose nearly 16% year-over-year, to £634.3 million ($806.9 million), from £548.9 million ($698.2 million).

The company’s other offerings include services that range from R&D, biomarker discovery development and commercialization, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

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