Catalent to Expand its Biologics Analytical Services with New Facility

Catalent announced on Dec. 14, 2022 that it is set to establish a new biologics analytical center of excellence in Durham, NC, within North Carolina’s Research Triangle, to offer analytical development and testing for biologic drug modalities, including cell and gene therapies.

Catalent plans to invest up to $40 million into the 80,000-ft2 facility. When complete, the facility 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. The facility is set to be completed by mid-2023 and is anticipated to support the hiring of over 200 scientists and technicians over the next five years.

“Catalent is committed to the continuous growth and expansion of its analytical capabilities to provide extensive CMC [chemistry, manufacturing, and controls] 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, in a company press release. “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.”