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.
Speakers
Jessica Shea
MilliporeSigma
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.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1hr
Language:English
Session 1:presented July 18, 2023
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