Catalent Pharma Solutions has announced the multi-site expansion of its analytical and process development capabilities for biologics. These investments include a significant expansion of bioassay and protein characterization capabilities at its Kansas City, MO, facility, and additional integrated analytical capabilities at its Madison, WI, bio-manufacturing facility.
This expansion reflects Catalent’s commitment to growth in biologics and to ongoing investment to support the development of better biologic treatments.
Catalent is a leading provider of standalone analytical services for large molecule products, with over 20 years of experience, and specific expertise in New Biologics Entities (NBEs), biosimilars, and antibody drug conjugates.
New investments have been made in response to increased industry demand for large molecule analytical services, strict regulatory expectations around NBEs, and additional characterization requirements for biosimilars. This most recent investment in Kansas City enables the facility to offer dual and complementary options for kinetic and quantitative binding assays for characterization and GMP testing.
“By listening to industry demands and continuously adding the latest in analytical technologies for biologics, Catalent can provide robust analytical services to clients, saving them from making costly investments and allowing them to focus on bringing their products to market faster,” commented Matthew Mollan, Catalent’s General Manager at Kansas City.
Catalent’s Madison, WI, site is a facility providing development, manufacturing and analytical services for NBEs and biosimilars. To expand its fully integrated platform, the Madison site is substantially increasing its large molecule characterization capabilities, which will be fully operational by January of 2016.
Catalent has also recently invested to expand process development capability at the Madison site, including integration of the Ambr 15® microbioreactor system into its cell line and upstream development process, providing overall reductions in timelines and increases in expression levels.
“Integrating a broad range of analytical services with our state-of-the-art GPEx cell line creation and manufacturing capabilities will allow us to seamlessly support our clients as they move through clinical development toward commercial production, further increasing Catalent’s position as a leading provider of biomanufacturing services,” commented Brian C. Riley, Catalent’s General Manager at Madison.