Evaluating extractables & leachables and performing a risk-based approach is a key step for single-use manufacturing. With USP <665> approval in 2021, transitioning to this new standard is ongoing for polymeric material used in single-use manufacturing.
Animal welfare and reducing animal testing is also a key initiative. Biological reactivity testing has traditionally used both in vitro and in vivo methods. With the updates to the USP chapters, positioning cell-based assays of USP <87> and ISO 10993-5 is the primary method for determining Biological reactivity.
In this webinar, you will learn about the new and changing compendial methods and what it means for pharmaceutical manufacturing.
Emprove® Program Manager
Jessica Shea is the Emprove® program manager responsible for filters, single-Use, and chromatography resin portfolios within MilliporeSigma. Previously, she was responsible for extractables and leachables global support for the BioReliance® validation services. She has more than 14 years of E&L experience, including method validation, designing of custom testing, and interpreting industry and regulatory guidance. Jessica has a B.S. in biochemistry and an MBA.
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