Catalent reported that it will establish a new biologics analytical center of excellence in Durham, within North Carolina’s Research Triangle, to offer standalone analytical development and testing for biologic drug modalities, including cell and gene therapies.
The CDMO plans to invest up to $40 million to fit out the 80,000 ft2 facility with advanced equipment and instrumentation, including automation and digitization capabilities. When complete it will provide solutions that include bioassays, physico-chemical testing, and product and process characterization, as well as process validation support, stability testing, in-process manufacturing and formulation analysis, and post-packaging identification. Catalent plans to complete the facility by mid-2023, which is expected to 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 labs to support the 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 [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.
“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.”