Catalent Biologics Opens New Single-Use Biomanufacturing Facility in Madison

Apr 25, 2013

Catalent Pharma Solutions, a provider of drug and biologic development services, delivery technologies and supply solutions, has officially opened a new biomanufacturing center of excellence in Madison. The facility, which was constructed in response to customer demand, is expected to quadruple Catalent's current biologics manufacturing capacity and extensively utilise single-use technology for greater flexibility and efficiency. It will allow the company to extend its offerings in the biologics sector while enhancing the efficiency and output of its proprietary GPEx cell line engineering technology as well as other mammalian cell lines.

Catalent recently acquired an exclusive license to market Redwood Bioscience’s proprietary SMARTag precision protein-chemical engineering technology for developing advanced antibody drug conjugates (ADCs) with enhanced potency, safety and stability. The technology adds to Catalent’s broad range of analytical and fill-finish services, including the company’s proprietary GPEx cell line expression system, which provides a platform for rapid development of stable, high yielding cell lines.

The Madison site marks a further expansion of Catalent’s capabilities to help its customers develop better biologic treatments. This 100 000-square-feet facility has been designed for flexible cGMP production, from 10 L up to 1000 L, and nonGMP production of up to 250 L. Manufacturing is supported by integrated analytical, formulation development and viral clearance capabilities, small-scale and large-scale process development laboratories as well as separate microbiology and quality-control functions.

Catalent has moved all its 89 employees from its current 43 000-square-feet facility in Middleton to the Madison site. The company also plans on eventually employing more than 100 people at the new facility.

"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," Barry Littlejohns, president of Catalent’s Biologics business said in a press release. "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."