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
Merck
Emprove® Program Manager
Jessica Shea is the Emprove® program manager responsible for filters, single-use, and chromatography resin portfolios within Merck. Previously, she was responsible for extractables and leachables global support for the BioReliance® validation services. She has more than 15 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.
Katharina Christlieb
Merck
Senior Marketing Operations Manager
Katharina Christlieb is a senior marketing operation manager at Merck, responsible for single-use, filtration, and chromatography product change communication and strategy. She has worked in life sciences for more than 16 years, having a broad experience in quality management systems including GMP, ISO 9001:2015, risk analysis, and continuous process improvements, as well as quality control and API/Excipient Production.
Katharina has a degree in chemistry from Ludwig-Maximilians-University Munich and a Ph.D. in biochemistry with a focus on protein characterization using Aptamer technology from the Rheinische Friedrich-Wilhelms-Universität Bonn.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
期间:1h
语言:English
场次 1:往期 July 18, 2023
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