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Catalent Biologics Opens New Single-Use Biomanufacturing Center of Excellence

Published: Tuesday, April 30, 2013
Last Updated: Tuesday, April 30, 2013
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State-of-the-art cGMP facility quadruples biomanufacturing capacity, extensively utilizes single-use technology for greater flexibility and efficiency.

Catalent Pharma Solutions will officially open its new, state-of-the–art biomanufacturing Center of Excellence in Madison, WI, at a ribbon cutting ceremony on Friday, 26th April, 2013. Constructed in response to customer demand, the new facility will quadruple Catalent’s current biologics manufacturing capacity, allowing the company to extend its offerings in the sector while enhancing the efficiency and output of its proprietary GPEx® cell line engineering technology as well as other mammalian cell lines.

The official opening follows the recent announcement that Catalent has acquired an exclusive license to market Redwood Bioscience’s ( proprietary SMARTag™ precision protein-chemical engineering technology for the development of advanced antibody drug conjugates (ADCs). Redwood’s novel, site specific protein modification and linker technologies, enable the generation of homogenous bioconjugates engineered to enhance potency, safety and stability. Combined with Catalent’s proprietary GPEx cell line expression system, for the rapid development of stable, high yielding cell lines, and a broad range of analytical and fill-finish services, the new Madison facility represents a further expansion of Catalent’s capabilities to help customers develop more and better biologic treatments.

Designed for flexible cGMP production, from 10L up to 1000L, and non-GMP production up to 250L, the facility features extensive use of single-use technologies and unidirectional 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.

Catalent has moved all its 89 employees from its current 43,000 sq ft facility in Middleton to the 100,000 sq ft Madison site and plans on eventually employing over 100 people at the new site.
“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.”

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