Catalent Pharma Solutions has opened its new biomanufacturing Center of Excellence in Madison, WI. The new facility quadruples current biologics manufacturing capacity and allows the company to extend its offerings as well as enhance the efficiency and output of its GPEx cell line engineering technology and other mammalian cell lines. Catalent has moved its 89 employees to the 100,000-sq.-ft. Madison site, and eventually plans to employ more than 100 people at the site.
Also, Catalent has recently acquired an exclusive license to market Redwood Bioscience’s SMARTag precision protein-chemical engineering technology for the development of advanced antibody drug conjugates (ADCs). Redwood’s site-specific protein modification and linker technologies enable the generation of homogenous bioconjugates engineered to enhance potency, safety and stability. Catalent will combine its GPEx cell line expression system with SMARTag for the rapid development of stable, high yielding cell lines, and a broad range of analytical and fill-finish services.
The facility is designed for flexible cGMP production from 10L up to 1000L, and non-GMP production up to 250L, and features single-use technologies and unidirectional flow. Manufacturing is supported by integrated analytical, formulation development and viral clearance capabilities, small-scale and large-scale process development labs, and separate microbiology and Quality Control functions.
“Our new biomanufacturing Center of Excellence has been specifically designed to meet our customers’ needs through improved delivery of integrated services in the areas of biologic development and manufacturing, and we will be pleased to welcome many of them on site at the official opening,” said Barry Littlejohns, president of Catalent’s Biologics business. “The extensive application of single-use technology greatly reduces the risk of cross contamination and gives us huge flexibility and scale, while our on-site capabilities enable us to provide our customers with solutions for even the most difficult to express proteins.”