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4th Annual Extractables & Leachables Summit 2024

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About 4th Annual Extractables & Leachables Summit 2024

One of the most important phases of the biopharmaceutical development process is the evaluation of extractables and leachables. Regulatory bodies are particularly concerned about the interactions of pharmaceutical products with container closure systems, drug delivery devices, and bioprocess manufacturing systems. Therefore, it is crucial to carefully evaluate the migration of mobile molecules from the materials and components used in the production and storage of pharmaceuticals.

We host a virtual conference where scientists, toxicologists, and E&L managers may exchange ideas about the most recent analytical approaches, regulatory updates, risk-based E&L programs, chemical characterization, and toxicological risk assessment. We also discuss analytical and safety thresholds, medical device materials, ISO 10993-18, and customized systems for various product kinds.

Come to our event and discover the latest approaches for extractables and leachables analysis and testing. This should help you greatly reduce the risks connected with E&L while also ensuring patient safety and product integrity.


Updated regulatory guidelines for E&L testing.
Implementation of a non-volatility test before quantitating E&L unknowns with a charged aerosol detector.
Toxicological assessments in E&L.
The current state and analytical challenges with the evaluation of E&L in pharmaceutical and medical device industries.
Approaches to the use of in silico methods in the toxicological assessment of extractables and leachables.
Sensitization safety assessment of extractables and leachables in pharmaceutical products.
Leachable risk assessment approaches: a comparison of USP <665>, biophorum, and other methods for assessing leachable risk in biopharmaceutical manufacturing systems.
Safety assessment of E&Ls: challenges with different administration routes.
E&L testing for medical devices.
Results of the elsie lab practices sub team’s surveys for understanding intra-lab method/procedure variations for the execution of extractable screening studies.
A novel simultaneous UHPLC-UV-CAD-HRMS multi-detector platform for comprehensive extractables and leachables analysis of pharmaceutical packaging and medical device materials.
Elastomer closures materials (TBC).
Leachable study of a parenteral vial products with complex and challenging formulations.

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

When and Where

Event date

Mar 07 - 08, 2024

Event location

Czech Republic

Event type

Event fees

Organized by


Audio Reviews (1)


Mar 2023

Anurag Bhattacharjee

Masters Student 

at OVGU Magdeburg

It was a balanced informative and a well structured summit with lots of information regarding extractables and liables. I recommend my colleagues and friends in my current organization to attend. It's further summit think.


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