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Pre Conference Workshops - Monday 3rd November 2025 Day One – Tuesday 4th November 2025 Day Two – Wednesday 5th November 2025
MORE THAN AN INTRODUCTION TO EXTRACTABLES AND LEACHABLES
Sponsored by SafeBridge
Description
The workshop offers more than just introductions to the topics, but practical case-studies and examples on how to put together all aspects to develop a compelling submittal to regulatory agencies for acceptance. 

Extractables and Leachables are a complex subject that requires a “team” of analytical chemists, toxicologists and regulatory experts to understand the nature of the drug product, test appropriately, conduct a toxicological risk assessment and interpret the data.
Allan W. Ader, Ph.D., DABT | Co-founder and Technical Director , SafeBridge Consultants, Inc.
Networking break
E&Ls RISK ASSESSMENT UNDER ICH Q3E,
ensuring quality method design and incorporating in silico approaches alongside existing safety data
Sponsored by Lhasa Limited
Description
Are you navigating the complexities of Extractables and Leachables (E&L) risk assessment under ICH Q3E? In this workshop, we will discuss the complexities of E&L risk assessment, particularly in light of the new ICH Q3E guideline. We will talk through how to efficiently design target methods based on a complete understanding of leachable risk within drug formulation and how to then effectively link leachable studies to extractable results. Another key focus will be working through practical workflows and optimisation techniques, highlighting how advanced in silico tools can overcome common challenges in E&L safety assessments, leading to faster, more cost-effective, and defensible outcomes for both the pharmaceutical and medical device industries.
Networking drinks reception
Registration and welcome refreshment
Chair’s opening remarks
UPDATE AND INSIGHTS TO ICH Q3E
ICH Q3E: A new global framework for Extractables & Leachables
This extended session introduces ICH’s draft guideline Q3E on Extractables and Leachables (E&L), offering insight into its global scope, principles for leachables risk assessment, and relevance across container closure and manufacturing systems. Attendees will gain a high-level understanding of the proposed framework and what it means for the future of E&L regulation.
Patricia Parris, Global Risk Assessment Services Toxicologist, Pfizer
Carsten Worsøe, Scientific Director, Novo Nordisk

Followed by open Q&A.
CULELATIVE EFFECTS
Practical consideration for cumulative E&L effects in drug product manufacturing.
  • How to estimate cumulative effects?
  • What kind of roles cumulative effect have in drug product safety?
  • Cumulative effects of PERL compounds in the drug product manufacturing

Tarja Nurmi | Senior Expert, Extractables & Leachables, Bayer
Evaluation of Cyclodextrin as an alternative simulation solvent to replace Polysorbate in Extractables studies
  • Issue: Polysorbate interferes with extractables detection in biopharmaceutical studies
  • Solution: Evaluated cyclodextrin as an alternative solvent
  • Benefits: Cyclodextrin offers less complex composition, reducing interference
  • Method: Comparative analysis of extractables profiles
  • Result: Cyclodextrin improves accuracy in extractables detection

Mohinish Sahai | Group Leader, Laboratory Services, GMP, PPD, part of Thermo Fisher Scientific
ANALYTICAL CHEMISTRY
Leachables from administration materials
  • Learn about the diversity of administration materials
  • Hear how formulation impacts leachables from administration materials
  • Understand the role of administration materials in leachables profiles

Jure Hren | Senior Expert Science & Technology , Novartis
Networking break
PFAS: when “forever chemicals” join the challenge of chemical characterization
  • Gain insight into the chemical characteristics of PFAS and how they’re applied across various industries
  • Examine current findings on the environmental persistence and potential health risks associated with PFAS exposure
  • Get an overview of the complex and evolving regulatory landscape surrounding PFAS at both regional and global levels
  • Understand the role and challenges of PFAS use in medical devices, including compliance considerations
  • Explore practical analytical techniques used to detect and evaluate PFAS in different materials and settings

Margherita Monico | E&L Senior Project Manager, Mérieux NutriSciences Italia
Transition from HPLC to UPLC: Method upgrade and retention time alignment for E&L studies using algorithmic prediction
  • HPLC and UPLC/MS analysis
  • Analytical method development
  • HPLC to UPLC transitioning
  • Retention time database normalization

Daniele Ubbiali | Project Leader – Extractables&Leachables, Eurofins Biolab Srl
Use of the retention index to secure correct identities in GC/MS
  • In GC/MS, Organic E/L-compounds are often identified via Mass Spectral Matching (MSM), which often leads to flawed identities
  • Considering the Retention Index (RI) of a compound, and comparing it with reference RI values can corroborate the identification obtained via MSM
  • 3140 compounds (using authentic standards) were evaluated for their MSM- and RI-score, compared to NIST23, which allows to establish acceptance and rejection criteria
  • Conclusions will be drawn on what it means – statistically – if these criteria would be applied
  • Several Case Studies will be presented on how to put these criteria into practice

Dr. Piet Christiaens | Scientific Director, Nelson Labs Europe
Extractables and Leachables: the complete workflow usingQTRAP LC-MS/MS technology
  • Enhance your analytical skills with hybrid QTRAP technology, offering precise compound analysis by seamlessly combining qualitative and quantitative purposes in one streamlined workflow
  • Experience improved accuracy in the qualification and quantification of co-eluting compounds without any compromise, unlocking new levels of precision in your analyses
  • Delve deep into your samples for a comprehensive target screening, leveraging the exceptional sensitivity of QTRAP technology to uncover nuanced insights and enhance your research capabilities

Ferran Sanchez | Global Senior Manager Product Marketing and Market Development, SCIEX
Networking lunch
E&L CASE STUDIES & SINGLE-USE SYSTEMS
An optimised QbD approach to Leachables analysis considering multiple biologic parenteral drug products
This presentation outlines a Quality by Design (QbD) strategy for leachables evaluation that maintains regulatory and scientific best practices while enabling method consolidation across multiple biologic/aqueous-based parenteral drug products, including alternate dosage forms. This approach enhances efficiency, reduces duplication, and ensures consistent analytical performance across related products.
Chris Noone (MDT), Senior Technical Specialist, Smithers
Extractables & Leachables in Lyophilized drug products: Hidden risks in a dry environment
  • Understand the importance of conducting a thorough risk assessment before analytical testing
  • Learnabout the key steps in risk analysis and the relevant documentation required for regulatory submissions
  • Gain insights into the development of analytical protocols, solvent selection, and the definition of Acceptable Exposure Threshold (AET)
  • Learn how to integrate toxicological risk assessment with analytical testing for comprehensive safety evaluations
  • Understand the different strategies for analysing leachables, including both untargeted and targeted methods
  • Explore a practical case study of E&L testing on a Vaccine syringe illustrating the real-world application of these principles

Dr. Valeria Mazzoni | E&L Project Coordinator , Neotron SPA, part of COTECNA group
In-depth assessment of Extractables and Leachables in microcarriers for adherent cell cultures processes
  • Learn about extractables profiles of styrene-based microcarriers, used for culturing adherent cells like mesenchymal stem cells in CGT applications, to enable risk assessment
  • Discover how kinetic models demonstrate effective PERL removal in perfused systems through wash-out, preventing accumulation over time
  • Understand that under dynamic conditions, PERL concentrations remain well below toxicological thresholds, unlike higher levels observed in static worst-case tests

Dr. Roberto Menzel | Product Manager, Biopreservation and Microcarriers, Advanced Therapy Solutions, Sartorius Stedim Biotech
Exhaustive studies: alternative approach and comparison with simulated use and Leachables data
  • Explore an alternative strategy to traditional exhaustive extraction studies for medical devices
  • Compare data from exhaustive extraction, simulated use, and actual leachables to assess relevance and accuracy
  • Examine the specific benefits of conducting exhaustive studies on individual medical device components

Alessio Mastrovito | Research Scientist, Vantive Healtcare
Networking break
INSIGHTS INTO USP 665
USP General Chapter <665>: Separating Fact from Fiction
Desmond G. Hunt | Senior Principal Scientist, USP
Navigating USP <665> and Emerging E&L Standards: Industry Strategies for Single-Use System Implementation
  • Transitioning from Gamma to X-Ray irradiation
  • Navigating the new USP <665> chapter from both supplier and end-user perspectives
  • An overview of the current and emerging E&L landscape and its applicability to Single-Use in the Biopharma industry
  • USP <665> and BioPhorum extractables data requirements from suppliers for Single-Use components
  • Information needed for assemblies and how this data is utilized in risk assessments
  • Addressing emerging E&L challenges

Muneeba Khalid | rincipal Process Characterization and Technology Scientist, Regeneron, BioPhorum
Panel discussion: Focused on practical application, harmonization, and industry alignment
Desmond G. Hunt, Senior Principal Scientist, USP
Muneeba Khalid, Principal Process Characterization and Technology Scientist, Regeneron, representing BioPhorum
Chair’s conference summary
Networking Drink Reception
Registration & Welcome Refreshments
Chair's Opening Remarks
LEACHABLES MODELING
Integrated assessment of formulation and storage effects on Leachables and E/L correlation for a vial/stopper container closure system
  • Identified critical formulation excipients and storage conditions as primary drivers of leachable profiles—both in identity and concentration—from a specific vial/stopper container closure system across diverse drug products
  • Demonstrated a robust extractables-to-leachables correlation based on data that captures real-world variability in drug product composition
  • Deepened the understanding of material behaviour and the complex interplay between specific formulations and leachable generation
  • Pinpointed key risk factors that can directly enhance and refine E&L risk assessment strategies for products utilizing this stopper component

Diane Hohenester | Principal Scientist, F. Hoffmann-La Roche
Towards regulatory acceptance of leachables modeling – objectives of an ELSIE subteam
  • Brief intro on fundamentals of leachables modeling (LM)
  • Role of LM within a leachables assessment risk framework
  • ELSIE Subteam on LM and motivation for whitepaper
  • Subteam core objectives:
    • How can degree of concern for leachables and model credibility (verification and validation) be leveraged
    • Pathways to reach regulatory alignment and acceptance

Thomas Egert | Analytical Development, Boehringer Ingelheim Pharmaceuticals
MEDICAL DEVICES & TOXICOLOGY
ELSIE Consortium Perspectives on FDA/CDRH draft guidance for chemical characterization
This presentation will focus on providing ELSIE’s perspectives on the FDA Draft Guidance on Chemical Analysis for Medical Devices Biocompatibility Assessment and will highlight 3 key points:
  • Study design: DBT selection, extraction conditions, sample analysis, and semi-quantification strategy 
  • Solvent selection: Material compatibility, solvent choice, alcohol/water mixtures and method qualification
  • Exhaustive extractions: NVR suitability and challenges, sample manipulation and replicates

Rodrigo Feliciano | Senior Principal Scientist, presenting on behalf of ELSIE
Networking break
Presentation on ISO 10993 (tbc)
Speaker tbc, Knoell
Toxicological risk assessment of E&L compounds of medical devices and its’ contribution in the biological risk assessment
  • Biological Risk Assessment of Medical Devices within the Risk Management Framework
  • Role of Toxicological Risk Assessment in the Biological Risk Assessment
  • Toxicological Risk Assessment of Chemical Constituents of Medical Devices – Practical Application of ISO 10993-17:2023

Alina Martirosyan | Sr. Scientific Manager Toxicology, B. Braun Melsungen AG
Toxicological risk assessment considerations for paediatric devices
Ron Brown | Toxicologist, Risk Science Consortium, LLC & US FDA (Retired)
Networking lunch
Making use of disseminated REACH registration data in biocompatibility evaluations
  • Understand the availability of data in REACH dossiers, and how the information requirements differ from ISO 10993
  • Navigate disseminated REACH dossiers effectively by understanding the IUCLID data structure and content layout
  • Assess data quality critically and understand potential pitfalls around test material identity and the limitations of read-across approaches
  • Use disseminated REACH data for ISO-compliant toxicological risk assessments

Chris Waine | Principal Toxicologist, bibra toxicology advice and consulting
Characterization of structural clusters for Extractables and Leachable (E&L) risk assessment
  • Developed a curated dataset of ~1,200 potential extractables and leachables (E&L) chemicals for analysis
  • Applied clustering to create a two-tier classification: 77 broad chemical groups and over 300 more refined sub-clusters
  • In silico screening identified 9% of chemicals as potential mutagens, 3% as strong/extreme dermal sensitizers, and 2% flagged for both concerns

Candice Johnson, Ph.D. | Senior Research Scientist, Instem
Performing confident read-across for E&L impurity safety assessments
  • Key considerations in conducting robust E&L safety assessments
  • Addressing emerging toxicological challenges through structured approaches
  • Leveraging in silico tools to strengthen read-across justification
  • Strategies for selecting appropriate analogs and building confidence in read-across
  • Integrating read-across into PDE derivation for regulatory and risk-based decision-making

Julia Martins | Scientist, Lhasa Limited
Chair's closing remarks and end of conference

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