3rd Annual Extractables & Leachables Summit 2023

CONFERENCE OVERVIEW

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.ade 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.

WE WILL TALK ABOUT

• Extractables and leachables assessments in biologics manufacturing processes.
• Characterization and cell-growth-inhibiting effect of bDtBPP analogue degradants released by polyolefin bioprocessing materials.
• Material changes - staying agile when supply chains are fragile.
• Toxicological assessment in E&L.
• UPLC/MS and GC/MS method development and validations of extractable and leachable compounds of a parenteral product.
• The use of computational methods in the assessment of extractables and leachables.
• Strategies for assigning compound identities and dealing with unknowns in E/L studies.
• Talk title: how to write a toxicological risk assessment to support extractables and/or leachables: a step-bystep process.
• USP’s perspective on the development of system suitability standards for the screening analysis of extractables and leachables.
• Regulatory tools for medical device evaluation: chemical risk calculators (CHRIS).
• FAQ: frequently asked questions related to rubber extractables.
• Advancements in E&L assessments – practical guide for the (bio) pharmaceutical manufacturer.
• E&L strategies for the registration and lifecycle management of inhaled pharmaceutical products in the current and future regulatory landscape.
• Extractables and leachables potential concerns with high potency APIs.
• Ensuring patient safety through accurate E&L testing.
• Analytical considerations in extractables and leachables testing of drug-device combination products.
• Workflow for identifying and monitoring antioxidant additives in singleuse systems.
• How to implement USP 665 requirements before 2026.
• Duration-based non-mutagenic thresholds of toxicological concern (TTC) for parenteral extractables and leachables.
• Using expert knowledge and machine learning to assess the mutagenicity and sensitisation potential of extractables and leachables.

WHO IS IT FOR?

CxO, VPs, Directors, Heads, Managers of

• Extractables and Leachables/ E&L
• Analytical Chemistry/ Analytical Development/Analytical Science
• Product Characterisation/ Risk Assessment
• Drug Development/ Drug Substance
• Drug Safety/ Compound Safety/ Toxicology
• Device Development/ Device Engineering/Container Development
• Good Laboratory Practice (GLP)/Good Manufacturing Practice (GMP)
• Manufacturing Science & Technology/ Single Use Systems
• Bioprocessing/ Bioproduction
• Regulatory Affairs & Compliance
• Materials Science/ Materials Selection/ Biocompatibility
• Packaging & Labelling
• LC-MS/ Mass Spectrometry

[Agenda] 3rd Annual Extractables & Leachables Summit 2023

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.