Evaluation of extractables and leachables (E&L) is a crucial step in the plan for product development. The interaction of pharmaceutical products with container closure systems, drug delivery devices and bioprocess manufacturing systems is a major concern for regulatory agencies. So, it is important to thoroughly assess the migration of mobile molecules from the components and substances used in the manufacture and storage of drugs.
Our virtual conference brings together scientists, toxicologists and E&L managers to discuss the most recent analytical strategies, regulatory updates, risk-based E&L programs, chemical characterization and toxicological risk assessment. We also bring up uncertainty factors in E&L testing, analytical and safety thresholds, medical device materials and ISO 10993-18, custom made mechanisms for different product types.
Join our event to learn innovative techniques for analyzing and testing for extractables and leachables in biopharmaceutical development. This should help you to significantly lower the risks associated with E&L and assure patient safety and product integrity.