SAFC’s Kansas culture site goes animal component-free
The Lenexa site, which makes dry powder culture media for the biopharma sector, underwent an extensive cleaning and process modification programme to remove all animal-derived products from manufacturing operations.
The firm has also set up a contamination remediation plan designed to fix any system breeches, including provisions for equipment decontamination, cleaning procedures, personnel and process flows, timelines and business continuity planning.
SAFC’s move coincides with increasing regulatory pressure and industry demand for medias, active pharmaceutical ingredients (API) and production reagents that are free of potentially allergenic animal components.
The emergence of bovine spongiform encephalopathy (BSE) in the 1990s and recognition that it could be transferred via animal proteins led regulators worldwide to ask manufacturers to minimise bovine-components in substances and medias used in drug production.
Since then both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have tightened up the rules on all animal derived components used in commercial-scale production medias in a bid to further enhance patient safety.
These rule changes have had the greatest impact on the biopharmaceutical manufacturing sector, which has traditionally been reliant on growth media containing animal proteins.
The expansion of the biologics sector and emergence of the follow-on biologics market is likely to further increase the demand for animal-free media products, creating a significant market for SAFC and its competitors.
In addition, the reversal of the US government ban funding for stem cell research looks set to intensify demand for ACF medias as the pharmaceutical industry inevitably seeks to produce commercial-scale quantities of stem-cell therapies in as safe a way as possible.
SAFC Biosciences’ president, Rod Kelley, said that: "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."
