State-of-the-art cGMP facility quadruples biomanufacturing capacity, extensively utilizes single-use technology for greater flexibility and efficiency
SOMERSET, NJ — Catalent Pharma Solutions, a leading provider of drug and biologic development services, delivery technologies and supply 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 (www.redwoodbioscience.com) 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."
Details on how to register for the opening ceremony can be found on the Catalent website: www.catalent.com and Catalent will be available to discuss the new facility on Booth 4571 at the BIO International Convention (April 22-25, 2013, McCormick Place, Chicago, IL).
Catalent Pharma Solutions is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics and consumer health products. With over 75 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable product supply. Catalent employs approximately 9,000 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and generates more than $1.7 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com.