5th Annual Extractables & Leachables Summit 2025

CONFERENCE OVERVIEW

The assessment of extractables and leachables is a critical step in the biopharmaceutical development process. The interactions between pharmaceutical products and drug delivery systems, bioprocess manufacturing systems, and container closing systems are of special concern for regulatory bodies. Therefore, it is necessary to carefully examine the migration of mobile molecules from the materials and components utilized in the production and storage of pharmaceuticals.

We organize a virtual conference to facilitate discussion on the most recent analytical techniques, regulatory updates, risk-based E&L programs, chemical characterization and toxicological risk assessment among scientists, toxicologists and E&L managers. We also cover ISO 10993-18, medical device materials, analytical and safety thresholds and customized systems for different product types.

Participate in our event to learn about the latest methods for testing and analyzing extractables and leachables. This can help you significantly reduce the risks associated with E&L while also assuring patient safety and product quality.

WE WILL TALK ABOUT

• Leachables and extractables as an essential component of product development and launch.
• Accurate analytical methods for the identification, measurement, and screening of E&L compounds.
• Exchanging knowledge from experts about how to plan, execute and publish E&L studies.
• Examining revisions to regulations to keep regulatory approvals compliant and cost-effective.
• Industry guidelines for toxicological risk assessment and chemical characterization.
• Comprehensive E&L evaluations for complex materials, products and processes.

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] 5th Annual Extractables & Leachables Summit 2025

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