In response to increasing demand for its biopharmaceutical products and bioprocess capabilities, Catalent Pharma Solutions expanded operations by opening a new 100,000 sq. ft. biomanufacturing Center of Excellence in Madison, Wisconsin last April.
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According to Catalent, the new facility will quadruple the company’s current biologics manufacturing capacity, allowing Catalent to extend its offerings in the sector while enhancing the efficiency and output of mammalian cell lines, including its GPEx® cell line engineering technology. The new facility also provides a broad range of analytical and fill-finish services.
Catalent’s new Madison facility represents a further expansion of the company’s ability to serve customers seeking to develop better biologic treatments. The official opening follows Catalent’s recent acquisition of an exclusive license to Redwood Bioscience’s proprietary SMARTag™ precision protein-chemical engineering technology for the development of advanced antibody drug conjugates (ADCs). This site-specific protein modification and linker technology enables the generation of homogenous bioconjugates engineered to enhance potency, safety and stability.
Designed for flexible cGMP production, from 10L up to 1000L, and non-GMP production up to 250L, the state-of-the-art facility extensively deploys single-use technologies within an extremely well-defined unidirectional production flow to greatly reduce cross contamination risk. Manufacturing is supported by integrated analytical, formulation development and viral clearance capabilities, small-scale and large-scale process development laboratories, 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,” 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.”
