Single-use plastic systems are being utilized more frequently, especially for COVID-19 vaccine manufacturing. However, issues regarding the standardization of quality information limit implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, we discuss approaches to decision-making based on the extractables data package. In addition, we highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
Speaker
Simone Biel, Ph.D.
Merck
Senior Regulatory Consultant
Simone Biel provides regulatory and scientific expertise to our customers and internal stakeholders globally with a focus on single-use technology. Over the years, Simone has supported biopharmaceutical drug manufacturers’ implementation of single-use technology in their manufacturing process. With her deep understanding of single-use technology market needs and industry trends, she is the subject matter expert to ensure that product performance meets quality and regulatory requirements. Simone holds a Ph.D. from the University of Frankfurt in microbiology.
Pharma and biopharma manufacturing
- mRNA
Duration:1h
Language:English
Session 1:presented July 15, 2021
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