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How to Prepare a Successful Leachables Study Strategy for Biologics

Join us and discover solutions to extractables and leachables study challenges.

Extractables and leachables (E&L) testing is expected when new drug products are submitted to the FDA for approval. The United States Pharmacopeia (USP) has published a guidance monograph on this, USP 1663 and 1664, and several years ago, the Product Quality Research Institute (PQRI) published comprehensive recommendations for the industry.

As FDA guidance on E&L testing is generally not prescriptive, and implementation is open to interpretation, leachable study designs, which are based on extractables studies of finished container closure components, can prove challenging.

Join our webinar on preparing a successful leachable study strategy for complex formulated drug products such as biologics. Andreas Nixdorf, Business Development Manager, Extractables and Leachables Testing at SGS Life Sciences, will provide solutions to E&L study challenges and explain how to avoid pitfalls when attempting to comply with E&L approval documentation.

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