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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
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SOURCE Sigma-Aldrich
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