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The BPOG Leachables Working Group has recently published a Best Practice guide for Leachables. It was developed to help biopharmaceutical and vaccines manufacturers to develop science-based, robust, and efficient approaches to handling the risk of leachable compounds that is associated with increasing use of single-use systems in manufacturing processes. The Best Practice guide is composed of three parts:
This webinar provides insight into the application of the best practices for leachables study design by end users, and will include a case study to highlight the importance of the study design.
A case study showcasing how a SUT supplier and a biomanufacturer can successfully work together to create an effective training program.