Catalent to Expand Its Biologics Analytical Services With New Facility in North Carolina

Catalent recently announced it is to establish a new biologics analytical center of excellence in Durham, within North Carolina’s Research Triangle, to offer comprehensive stand-alone analytical development and testing for biologic drug modalities, including cell and gene therapies.

Catalent plans to invest up to $40 million to fit out the 80,000-sq-ft facility with state-of-the-art equipment and instrumentation, including automation and digitization capabilities. When complete, it will provide comprehensive solutions that include bioassays, physico-chemical testing, and full product and process characterization, as well as process validation support, stability testing, in-process manufacturing and formulation analysis, and post-packaging identification. Catalent expects to complete the facility by mid-2023, which will support the hiring of over 200 scientists and technicians over the next five years.

The new CGMP facility will complement Catalent’s biologics analytical center of excellence in Kansas City, MO, which is currently undergoing a $12-million expansion project to add new analytical development laboratories to support the growing demand for assay development in both traditional biologics and advanced modalities, such as antibody-drug conjugates, cell and gene therapies and mRNA vaccines.

“Catalent is committed to the continuous growth and expansion of its analytical capabilities to provide extensive CMC support and solutions that are compliant with current good laboratory and manufacturing practices. By establishing significant additional capacity on the East Coast, we can offer our customers greater flexibility and expanded support services across the biologics and advanced modalities pipeline,” said Jeremie Trochu, Catalent’s Division Head for BioAnalytics. “Our Kansas City and Durham sites will together provide comprehensive services and expert solutions to companies seeking analytical support across all phases of development, ultimately reducing bottlenecks and creating an accelerated path to regulatory approval for both drug substance and drug product programs across a wide range of advanced therapies.”

For nearly three decades, Catalent Biologics has built capabilities and expertise in development, manufacturing, and analytical services, now spanning new biological entities, biosimilars, plasmid DNA, cell and gene therapies, vaccines, sterile injectables, mRNA, and antibody-drug conjugates. It has developed 600+ antibodies and 80+ recombinant proteins, with more than 120 active clinical trials and 16 marketed biotherapeutics use GPEx cell line engineering technology. More than 45 commercially approved products have employed Catalent Biologics’ manufacturing and packaging capabilities. Using advanced technologies and tailored solutions from clinical to commercial supply, Catalent brings better biologic and advanced treatments to patients, faster.

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians. Headquartered in Somerset, NJ, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information, www.catalent.com