DSM and the FDA join together for innovative partnership in PAT

January 19, 2008 — /PARSIPPANY/ — DSM Pharmaceuticals Inc. and the Food and Drug Administration (FDA) have recently signed an agreement to collaborate on a project involving statistical quality by design methodology during pharmaceutical manufacturing. Dr. Barry Gujral of DSM and Dr. Maziar Kakhi of FDA will jointly work to build mathematical models using quality by design, statistical process control, design space, and risk analysis methodologies. The goal of this project is to recommend changes that support the pharmaceutical manufacturing sector’s focus on proactively managing manufacturing processes. This will further enable the pharmaceutical sector to reduce waste, enhance efficiency, and manufacture drugs with improved consistency and quality.

The project is in line with the process analytical technology initiative FDA released in September 2004 to bring more innovations in pharmaceutical manufacturing. “This initiative with the FDA is a big step toward developing more innovative processes in the manufacturing of pharmaceuticals and will benefit current and future customers by improving efficiencies in the manufacturing process,” says Terry Novak, president and business unit director for DSM Pharmaceuticals Inc.

About DSM Pharmaceuticals Inc.

DSM Pharmaceuticals, Inc. a business unit of DSM Pharmaceutical Products, is a global provider of custom manufacturing services to the pharmaceutical and biopharmaceutical industries. Our breadth of manufacturing services include the areas of steriles, orals, and topicals, including dose form manufacturing, scheduled drugs, clinical manufacturing, fill finish manufacturing, and lyophilization services.

About DSM Pharmaceutical Products

DSM Pharmaceutical Products is a global provider of high quality custom contract manufacturing services to the pharmaceutical and biopharmaceutical industries. DSM Pharmaceutical Products provides contract manufacturing services including advanced intermediates, active ingredients (API’s), amino acids and derivatives, mammalian cell culture production (fed-batch and perfusion) of monoclonal antibodies, proteins, vaccines, finished dose manufacturing of solid dose, scheduled drugs, liquids, aseptic liquid, and lyophilized products.
From clinical to commercial services, DSM focuses the right resources on providing the highest level of service and quality while applying innovative solutions to satisfy customers’ unique manufacturing and development needs.

Visit www.dsm.com


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