Collagenase Raw Material Certification
Although it does not affect the majority of research customers, please be aware that the FDA has issued a 'Risk of BSE in Collagenase Enzymes' notice to all FDA-regulated users of Collagenases. (5/23/07 FDA Collagenase Note) Worthington currently provides Collagenase to many such customers for which this issue is likely to arise.
We recently drafted this document (Collagenase Products Raw Material Certification) in response to the FDA's letter to all regulated Collagenase users. Please note that although Worthington is not currently a cGMP manufacturer of collagenase we operate under GMP guidelines and are ISO9001:2000 Certified. In addition and most importantly, Worthington has never used Brain Heart Infusion (BHI) media in our collagenase production process. Other low-risk animal sourced raw materials are of USDA or equivalent inspected and approved as suitable for human consumption.
We have also been working on developing a completely Animal Origin Free (AOF) collagenase product and have raised the priority of this due to recent inquiries. We now have AOF Collagenase evaluation material available for sampling and welcome the opportunity to provide evaluation samples of lots that are available if interested.
Please let us know if we can be of additional assistance or if any additional information is required by any of your customers. We look forward to continuing to provide collagenase to meet the technical and regulatory requirements of the market.
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