August 29, 2007 — /PRnewswire/ — ST. LOUIS, MO — SAFC(R), a member of the Sigma-Aldrich Group, has announced a $4.5 million capacity expansion program at its flagship SAFC Pharma(TM) high-potency API (HPAPI) facility in Madison, WI. The program, scheduled for commission in early 2008, will add additional cGMP pilot plant and kilo lab capacity and complement the new XRPD (X-ray Powder Diffraction) analytical equipment for advanced solid-form testing due to become operational this month.
These developments build upon existing capabilities and expertise in potent compound handling at the Safebridge(R)-certified SAFC Madison facility and add to a $12 million, 38,000-sq.-ft. expansion program completed in 2006.
In the $4 million expansion, SAFC is adding additional capacity to its custom HPAPI manufacturing by introducing two 400-liter cGMP pilot plant reactors and two 100-liter cGMP portable jacketed reactors into a 1200-sq.-ft. dedicated, large-scale kilo lab. The addition will enable larger-scale chromatography for process purification, catering to future business requirements.
For solid-form testing and analysis, SAFC Pharma has installed and qualified a Bruker D8 Advance X-ray Diffractometer in a new dedicated analytical laboratory, providing U.S. customers with on-site cGMP and XRPD analysis of potent compounds. Rapid sample testing at the Madison site combines with data analysis and evaluation performed at SAFC Pharmorphix(TM) facilities in the U.K. Acquired in mid-2006, SAFC Pharmorphix specializes in solid-form research and is completing a multi-phase, $1.2 million expansion program at its labs.
SAFC president Frank Wicks comments, “As regulatory requirements align with the increasing complexity of drugs, solid-form testing, analysis, and optimization are becoming key elements in the drug development process. Additional and enhanced capabilities at SAFC Pharma’s Madison facility mark a timely expansion to the scope and value of our HPAPI offering and are reflective of SAFC’s ability to support its customers throughout the drug development cycle.”
SAFC Pharma is focused on cGMP manufacturing, process development, and contract services for small organic APIs and advanced intermediates, and the development of large-molecule biopharmaceuticals.
SAFC(R) is the manufacturing group within Sigma-Aldrich that focuses on high-purity inorganics for high technology applications, cell culture products, and services for biopharmaceutical manufacturing, biochemical production, and complex, multi-step organic synthesis of APIs and key intermediates. SAFC has manufacturing facilities around the world dedicated to providing manufacturing services for companies requiring a reliable partner to produce their custom manufactured materials. SAFC has four operating segments — SAFC Pharma(TM), SAFC Supply Solutions(TM), SAFC Biosciences(TM), and SAFC Hitech(TM) — and had annual sales of nearly $500 million in 2006. SAFC is one of the world’s 10 largest fine chemical businesses. For more information about SAFC, please visit www.safcglobal.com.
Sigma-Aldrich is a leading life science and high-technology company. Its biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease, and as key components in pharmaceutical and other high-technology manufacturing. The company has customers in life science companies, university and government institutions, hospitals, and in industry. More than 1 million scientists and technologists use its products. Sigma-Aldrich operates in 36 countries and has 7,700 employees providing excellent service worldwide. Sigma-Aldrich is committed to accelerating customer success through leadership in life science, high technology, and service. For more information about Sigma-Aldrich, please visit www.sigma-aldrich.com.
Dr. Frank Wicks, president, SAFC
Richard Kerns of Northern Exposure
E-mail: [email protected]