4th Annual Extractables & Leachables Summit 2024 - uventia

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

[Agenda] 4th Annual Extractables & Leachables Summit 2024

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

Speaking Companies
Previous Events

● 3M ● Albhades ● ALK-Abelló S.A. ● Analytical Expertise Center, MoH of Azerbaijan Republic ● Antibiotice SA ● AstraZeneca ● B. Braun Medical Industries Sdn. Bhd ● B. Braun Medical SA ● Bausch Health ● Baxter Healthcare ● Bayer AG ● BD ● Bicycle Therapeutics ● BioConnection BV ● Biogen ● Brainfarma Industria Quimica e Farmacêutica S.A. ● Chorley Consulting Ltd ● CleanControlling Medical GmbH & Co. KG ● CSL Behring ● Datwyler ● Donaldson ● Donaldson BV ● Dr. Anika Schroeter e.U. ● DuPont ● E.L-Xpert Ltd ● Element Material Technology ● ELSIE Consortium ● EQUITOX ● Fastnet Biopharma ● Fischer PreclinTox Consulting ● Fresenius Kabi ● Gateway Analytical ● GBA Pharma GmbH ● GE HealthCare ● Gilead Sciences ● Gilead Sciences, Inc. ● Greg Erexson Toxicology Consulting ● GSK ● ICU Medical ● Incyte ● Instem ● Intertek Schweiz AG ● Johnson & Johnson ● Laboratorios Normon SA ● LACER, S.A.U ● Lhasa Limited ● Lonza ● Lonza Drug Product Services ● Made Consulting Ltd Oy ● Mallinckrodt Pharmaceuticals ● Merck Group ● Merck KGaA ● Neotron Spa ● Octapharma ● Padagis Israel Pharmaceuticals ● Pharmaceutical Firm Darnitsa ● PHOX Consulting e.U. ● Polpharma Biologics S.A. ● PolyCine GmbH ● Promega Corp ● Quinta-Analytica, s.r.o. ● Safetree Consulting e.U. ● Sartorius ● SCC Scientific Consulting GMBH ● SEPTODONT ● SGS Health Science ● Sun Pharmaceutical Industries Ltd. ● Terumo Blood and Cell Technologies ● Teva Pharmaceuticals ● Teva Pharmaceuticals Ireland ● Therapeutic Goods Administration ● Thermo Fisher Scientific ● Tofwerk AG ● U.S. Pharmacopeia ● United States Pharmacopeia ● Universidade de São Paulo ● US Food and Drug Administration ● Waldemar Link ● Westlake ● Wonderboom, Inc. ● WuXi AppTec

● 3M ● Aché ● Adjutant Solutions Group LLC ● AGC Biologics ● Albhades Provence ● ALK-Abelló S.A. ● Aptar Pharma ● AstraZeneca ● Athens Analysis Laboratories ● B.Braun Melsungen AG ● Baxter Healthcare ● Bayer AG ● BBraun Avitum Italy SpA ● Becton Dickinson ● Biogen ● BioNTech ● Boston Scientific ● BSC International Medical Trading ● Carl Zeiss Meditec AG ● Charles River ● Cytiva ● Dalton Chemical Laboratories Inc. ● Deva Holding A.Ş. ● Eli Lilly ● Eli Lilly & Co. ● Gador ● Galapgos NV ● Galderma ● Gilead Sciences ● GlaxoSmithKline Biologicals ● GlaxoSmithKline Biologicals Kft. ● Greiner Bio-One GmbH ● GSK Vaccines ● Hall Analytical ● HORIBA Scientific ● Incyte ● Incyte Biosciences Tech Ops ● Intertek (Schweiz) AG ● L.Molteni & C. dei F.lli Alitti SpA ● LGC Standards ● Lhasa limited ● Lonza ● Medela AG ● Merck KGaA ● Nelson Laboratories ● Niutec AG ● Norbrook Laboratories Ltd ● Norner AS ● Novartis Pharma AG ● Octapharma AB ● Par Pharmaceutical ● Pharma Mar ● Pliva Croatia Ltd. ● PLIVA Hrvatska d.o.o. ● QUINTAANALYTICA s.r.o. ● Regeneron ● Safetree Consulting e.U. ● Sandoz ● Sanofi ● Sanofi-Aventis ● Sanofi-Aventis R&D ● Sartorius ● Sartorius Stedim Biotech GmbH ● Sumitomo Dainippon Pharma Co., Ltd. ● Takeda Pharmaceutical Co. Ltd. ● Teva Pharmaceutical Industries LTD ● Teva Pharmaceuticals Ireland ● TRIS Pharma ● UCB Biopharma SRL ● Waters Corporation ● Waters GmbH ● West Pharmaceutical Services ● Xellia d.o.o.

Speaker Board
Katherine Lovejoy
Application Chemist
Thermo Fisher Scientific
Jason Creasey
Managing Director
Maven E&L Ltd
Divya Regulagedda
Manager (Global SME)
Chemo Group
Jianwei Li
Principal E&L
Chemical Characterization Solutions LLC
Frank Liu
Director, Safety and Toxicology
Estee Lauder Companies
Erika Udovic
Senior Principal Scientist
Novartis Pharma AG
Senior Research Scientist
Dujuan Lu
E&L Manager/Global Leader
SGS Health Science
Charlie Modlin
Application Scientist
Lhasa Limited
Jianfeng Hong
Sr. Research Scientist
Fresenius Kabi
Douglas Kiehl
Research Advisor
Eli Lilly
Steve Zdravkovic
Research Scientist II
Baxter Healthcare
Etienne Michel
Global QA for E&L
GSK Vaccines
Marine Lepoutre
E&L Global SME
GSK Vaccines
Clemens Guenther
Director, Senior Expert Nonclinical Safety
Bayer AG
Andrew Feilden
European E&L Strategic Director
Bicycle Therapeutics

Summit Agenda

◆  The differences between Advanced Therapy Medicinal Products (ATMP) and traditional biopharmaceutical products create new challenges for extractables and leachables (E&L) assessments. These issues are particularly important considering the increasing reliance on single-use systems (SUS). While SUS extractables data can serve as a basis for assessing ATMP applications, there are significant opportunities to improve assessment tools for exposure estimation and toxicological evaluation. In ATMP applications cells or viruses are the therapeutic product and a patient exposure estimation for leachables must consider both the liquid phase and the therapeutic biological material.

We tested forty-five commonly found extractbales and processing aids in a high-throughput screening cell-painting assay using a human cell line. Results showed that most compounds did not create a response in the > 550 cell features analyzed. Only three candidates were found to show an effect in this assay, including the antioxidant degradant bDtBPP, known to be detrimental to cell growth. Further, a concept is developed that allowes to model process equipment-related leachables (PERLs) exposure in an ATMP production environment.

In summary, cell-based products' exposure to PERLs is expected to fall far below critical effective concentrations. Nonetheless, avoiding materials of construction containing extractables with a known detrimental effect to cells is advisable.

Sartorius Stedim Biotech GmbH, DE

◆  HPLC with 3 orthogonal detectors allows quantitation of unknowns by charged aerosol detectorand identification by easy-to-use low resolution MS

◆  Classification of unknowns as non-volatile or semi-volatile in the CAD reduces the uncertainty factor and improves quantification by surrogate standard.

◆  When using an inverse gradient, improved mixing with an inline capillary mixer after the merge point of the analytical and inverse gradients reduces inter-compound %RSD

Thermo Fisher Scientific, DE

◆  PQRI's recommendations for analytical and safety thresholds.

◆  The QSAR application and qualification standards.

◆  Analyzing toxicological risk and toxicity data.

Bayer AG, DE

◆  The safety and analytical science expectations of E&L from the perspective of a quantitative “global” space of extractables and leachables in volatility, hydrophobicity, and molecular weight.

◆  A critical review of the current state of analytical testing strategies, including uncertainty on E&L testing.

◆  A critical overview of the major analytical challenges in solvent choice, sample treatment, mass balance, method sensitivity, response factor, accuracy of quantitation and identification, etc, with specific examples.

◆  Tips for choosing an analytical partner.

Chemical Characterization Solutions, LLC, USA

◆  Discusses various contexts in which in silico methods are applied in E&L assessments.

◆  Defines the fitness-for-purpose of in silico models in these contexts.

◆  Demonstrates how in silico profiling could be used to support read-across assessments.

Instem, USA

◆  Sensitization potential of extractables and leachables: a challenge.

◆  Sensitization safety assessment proposal for extractables and leachables.

◆  A hypothetical case study: the application of the proposal.

Estee Lauder Companies, USA

◆  There is no agreed format for leachable risk assessment.

◆  Both USP and Biophorum have published guidance.

◆  Presented is an alternative approach that might be considered, covering both severity and probability of leachable risk.

Maven E&L Ltd, UK

◆  Introduction to general safety and regulatory considerations for extractables/ leachables (E&Ls) in pharmaceutical products.

◆  Considerations for ocular administration routes.

◆  Assessment strategies for intrathecal (IT) route of administration (tentative at this stage, might be adjusted later).

Novartis Pharma AG, CH

◆  Chemical characterisation of medical device materials and ISO 10993-18.

◆  Evaluation of biocompatibility and toxicological risk.

◆  The verification of analytical methods.

Chemo Group, ES

◆  Annecdotely, it’s been stated that extractable screening data obtained between laboratories will be unaligned to at least some extent in the qualitative and/or quantitative profiles reported, which has been hypothesized to be attributable to differences in the methods and procedures used.

◆  To that end, ELSIE has surveyed a large number of CRO and pharmaceutical (sponsor) companies with the goal of better understanding variations in methods and lab practices used between labs with the goal of understanding the extent of such variation that currently exists in the E/L field.

◆  This presentation will discuss the data obtained from these surveys, highlighting areas of alignment, or lack thereof, for key method/procedural aspects including surrogate standard selection, uncertainty factor determination and usage, system suitability parameters, and relevant methodology variables.

Baxter Healthcare, USA

◆  Composition of elastomers used for pharmaceutical applications.

◆  Material composition and extractables.

◆  How to minimize extractables/leachables from elastomeric closures.

West Pharmaceutical Services, USA

◆  Extractable study results.

◆  Leachable simulation study.

◆  Target Leahcable test method validations.

◆  Leachable Test Results (6 months and 24 months).

◆  Summary and Conclusions.

Fresenius Kabi, USA

Event Details