Residual impurities can potentially be introduced into the biopharmaceutical manufacturing process at a variety of stages. Recently, nitrosamines and elemental impurities have been a concern for regulatory agencies. These impurities originate from various raw materials, process chemicals, and manufacturing equipment. Single-use systems (SUS) incorporate a number of plastic components. A key concern related to plastic SUS is potential leachable compounds from contact materials. It’s essential to obtain information on leachables as well as nitrosamines and elemental impurities. This webinar looks into how to evaluate nitrosamine and elemental impurity risk related to SUS and filters.
In this webinar, you will:
- Understand the potential of nitrosamine contamination
- Learn how to leverage industry, supplier, and scientific expertise to assess the risk of elemental impurities taking advantage of ICH Q3D guidance on biologic drug manufacturing
- See a case study using Emprove® Elemental Impurities to help you conduct an efficient elemental impurities safety evaluation D46
Speakers
Janmeet Anant, Ph.D.
Merck
Senior Regulatory Consultant
Janmeet Anant is a senior regulatory consultant, focused on biopharmaceutical manufacturing at Merck. Janmeet serves as an executive board member for the Bioprocess Systems Alliance (BPSA) and a member of the Regulatory Governance Team at BioPhorum.
He has more than 20 years of experience, moving through technical application roles for chromatography, filtration, cell culture and, most recently, regulatory consulting. Janmeet has a B.S. in Chemistry and a Ph.D. in Pharmacology.
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.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
Language:English
Session 1:presented September 30, 2021
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