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SAFC Biosciences(TM) Completes Conversion of Lenexa Media Milling Facility to Animal Component Free
Date:3/26/2009

Customer Demand for ACF Manufacturing Drives Aggressive Conversion Program

ST. LOUIS, March 26 /PRNewswire-FirstCall/ -- SAFC Biosciences(TM), a leading provider of cell culture materials and services for upstream and downstream processes in the biopharmaceutical industry and a business segment within SAFC(R), a member of the Sigma-Aldrich Group (Nasdaq: SIAL), today announced it has completed the conversion of its dry powder cell culture media continuous milling production site in Lenexa, Kansas to animal component free (ACF) status. Part of a global facility conversion strategy, this is the first of several similar conversions planned by SAFC Biosciences to support growing customer requirements for ACF manufacturing.

"As a leader in the biological manufacturing market, our customer-centric approach aligns closely with expanding customer requirements for safer ACF manufacturing models," commented Bruce Lehr, Director of Marketing at SAFC Biosciences. "The comprehensive conversion of this facility to ACF status is driven by market requirements that are influenced by regulatory guidance for reducing animal component risk, and by an expanding focus on 'second generation' biologics-based drugs that require ACF production platforms."

During this facility's ACF conversion, extensive cleaning conversion protocol was completed and systems and procedures were reviewed and modified appropriately. Major factors addressed during this process included comprehensive:

  • Cleaning protocol and documentation;
  • Facility analysis on air, personnel, equipment and process flows;
  • Raw material procedures - from receipt, inspection/sampling, quarantine and storage to release;
  • SOPs/Ops/Procedures review against ACF requirements, with changes implemented to cover product sampling, personnel and product flows, and cleaning;
  • Personnel training records review and pertinent training updates prior to ACF conversion;
  • Risk analysis performed on all equipment and components used in ACF areas;
  • ACF status and manufacturing information collected on all raw materials;
  • Contamination remediation plan instituted for any system breech, including provisions for equipment decontamination, cleaning procedures, personnel and process flows, timelines and business continuity planning.

"Moving our Lenexa media milling facility to ACF status was motivated by SAFC Bioscience's dedication to understanding our biopharmaceutical client's requirements and providing them with appropriate solutions to fit those needs," said SAFC Biosciences President, Rod Kelley. "Conversion of this facility is part of our Company's continuing strategy to offer expertise and appropriate manufacturing processes that are expected to help global customers mitigate risk, increase operational efficiencies and meet regulatory requirements. Conversion of additional facilities to ACF status is scheduled for completion within the next 12 months in Europe and the United States."

About SAFC: SAFC(R) is the custom manufacturing and services 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 the manufacturing of 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 focus areas - SAFC Pharma(TM), SAFC Supply Solutions(R), SAFC Biosciences(TM), and SAFC Hitech(TM) - and had annual sales of $624 million in 2008. SAFC is one of the world's 10 largest fine chemical businesses. For more information about SAFC, visit www.safcglobal.com.

About SAFC Biosciences: Headquartered in Lenexa, Kansas, SAFC Biosciences is a leading provider of cell culture materials and development services for upstream and downstream processes in the biopharmaceutical industry. Providing an integrated services package in mammalian cell culture media development, along with analytical and regulatory support, SAFC Biosciences employs a wealth of industry experience and scientific know-how to deliver reliable, consistent solutions that accelerate customer success - from development through to commercialization. The unit has a 35-year history as a manufacturing partner providing leading biopharmaceutical companies with the broadest range of highly customized products and services possible. SAFC Biosciences has six production facilities in the United States, Europe and Australia, and employs 600 people.

About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company. Its chemical and biochemical products and kits are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development and as key components in pharmaceutical, diagnostic and other high technology manufacturing. The Company has customers in life science companies, university and government institutions, hospitals, and in industry. Over one million scientists and technologists use its products. Sigma-Aldrich operates in 38 countries and has 7,900 employees providing excellent service worldwide. Sigma-Aldrich is committed to Accelerating Customer Success through Innovation and Leadership in Life Science, High Technology and Service. For more information about Sigma-Aldrich, please visit its award-winning Web site at http://www.sigma-aldrich.com.

Cautionary Statement: This release contains forward-looking statements relating to future performance, goals, strategic actions and initiatives and similar intentions and beliefs and other statements regarding the Company's expectations, goals, beliefs, intentions and the like, which involve assumptions regarding the Company's operations and conditions in the markets the Company serves. The Company does not undertake any obligation to update these forward-looking statements.

SAFC(R), SAFC Supply Solutions(R) and Sigma-Aldrich(R) are registered trademarks and SAFC Pharma(R), SAFC Biosciences(TM) and SAFC Hitech(TM) are trademarks of Sigma-Aldrich Biotechnology L.P. and Sigma-Aldrich Co.


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