SAFC Biosciences, a member of the Sigma-Aldrich Group, has completed the conversion of its dry powder cell culture media continuous milling production site in Lenexa, KS to animal component free (ACF) status. This is the first of several conversions planned by SAFC Biosciences to support 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.”

According to an SAFC statement, major factors addressed during the conversion process included: 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 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, 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 U.S.”