Somerset-based Catalent, a $5 billion global leader in enabling biopharma, cell, gene and consumer health partners to optimize development, launch and supply of better patient treatments across multiple modalities, announced Wednesday that it will invest $40 million to establish a new biologics analytical center of excellence.
Unfortunately for New Jersey, the facility will be based in Durham, North Carolina.
Catalent plans to fit out an 80,000-square-foot facility within North Carolina’s Research Triangle. The facility will enable Catalent to offer comprehensive standalone analytical development and testing for biologic drug modalities, including cell and gene therapies.
The facility will include 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.
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, the company generated nearly $5 billion in revenue in its 2022 fiscal year.
The new current good manufacturing practice facility will complement Catalent’s biologics analytical center of excellence in Kansas City, Missouri, 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.
Jeremie Trochu, Catalent’s division head for bioanalytics, said the new facilities are all a part of the company’s growth plans.
“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,” he said. “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.
“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.”