4th Annual Extractables & Leachables Summit 2024 - uventia

4th Annual Extractables & Leachables Summit 2024

4th Annual Extractables & Leachables
Event Details


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

● Agilent Technologies Deutschland GmbH ● AnaBioTec ● Bacthera AG ● Baxter Healthcare ● Baxter International Inc. ● Bayer AG ● BBraun Avitum Italy ● Becton Dickinson ● BSP Pharmaceuticals S.p.A. ● Catalent Pharma Solutions ● Charles River ● Chattam (Sanofi) ● Chemical Characterization Solutions, LLC ● Chemo Group ● CleanControlling Medical GmbH & Co. KG ● Crossject ● CSL Vifor ● Dalia Global Services ● Dalton Pharma ● Eli Lilly ● Estée Lauder Companies ● GE HealthCare ● GE Healthcare AS ● GlaxoSmithKline Biologicals Kft. ● GSK (Pharma) ● GSK Vaccines ● Instem ● Intertek (Schweiz) AG ● Lausanne University Hospital ● Lhasa Limited ● LIQVOR CJSC ● Maven E&L Ltd ● Medline Industries LP ● Merck KGaA ● Mirum Pharma ● Nattrmann (Sanofi) ● Norgine ● Novartis ● Novartis d.o.o. ● Novartis Pharma AG ● Opella (Sanofi) ● Pharmacelsus GmbH ● Pharmaceutical company Darnitsia ● Philips Electronics Nederland B.V. ● Preclintox Services, LLC ● Quinta-Analytica, s.r.o. ● ResMed ● Safetree Consulting e.U. ● Sandoz Development Center ● Sartorius Stedim Biotech GmbH ● Septodont ● SEQENS ● SGS Health Science ● Takeda Manufacturing Austria AG ● TEVA branded pharmaceutical products R&D, Inc. ● Teva Pharmaceutical Industries Ltd ● Teva Pharmaceuticals Ireland ● Thermo Fisher Scientific ● Vimta Labs Limited ● West Pharmaceutical Services ● Westlake Compounds Italy S.r.l. ● Zoetis Belgium SA

● 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
Tobias Weimer
Product Specialist LC-MS
Agilent Technologies Deutschland GmbH
J. Susanne Becker
Head of Extractables and Leachables Labs
Intertek (Schweiz) AG
Will Parker
E&L Technology Manager
West Pharmaceutical Services
Ana Kuschel
Principal Scientific Affairs
West Pharmaceutical Services
Armin Hauk
Principal Scientist
Sartorius Stedim Biotech GmbH
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
Candice Johnson
Senior Research Scientist
Frank Liu
Director, Safety and Toxicology
Estee Lauder Companies
Erika Udovic
Senior Principal Scientist
Novartis Pharma AG
Mourad F. Rahi
Senior Consultant Chemist
Preclintox Services, LLC
Dujuan Lu
E&L Manager/Global Leader
SGS Health Science
Charlie Modlin
Application Scientist
Lhasa Limited
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

Summit Agenda

◆  E&L safety assessment in cell and gene therapies (CGT) is challenging.

◆  While suitable extractables data are available, exposure estimations to patients and the ex vivo manipulated biological material need to be improved by exposure modelling.

◆  Additionally, data for toxicological relevant end points for the ex vivo manipulated cells are required.

◆  It will be shown that morphological profiling with a cell painting assays (CPA) using human cells allows to identify potential detrimental effects relevant for E&L safety assessments.

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

◆  Set of Extractables Study under realistic worst-case conditions.

◆  Leachables Simulation Study using drug substance/product solution.

◆  Selections of target compounds, method development and validation according to ICH.

◆  Case studies showing problems and possible solutions.

Intertek, CH

◆  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

◆  Introduction to the assessment of E&Ls, particularly through an in silico lens.

◆  How in silico statistical models, expert-knowledge based models, and combined approaches can aid in E&L assessments.

◆  How Lhasa’s in silico solutions make use of combined model approaches to effectively predict hazard and potency of E&Ls.

◆  A worked case study demonstrating the implementation and efficacy of in silico approaches to estimate hazard and potency for E&Ls.

◆  The future of Lhasa’s solutions in the E&L space.

Lhasa Limited, USA

◆  The shortfalls of system suitability for determination of limit of detection as routinely performed for chemical characterization of solvent extracts of medical devices.

◆  The results and impact of a limited laboratory investigation on the effect of incubation on spiking selected standards commonly used for identification and quantification of extractables.

◆  Biocompatibility testing failure and identification of root cause.

◆  Recommendations to improve extraction and identification of reactive/toxic substances.

Preclintox Services, LLC, USA

The goal will be to present how to manage the cumulative effect and to explain which simplifications can be implemented for extractable studies and patient exposure scenario:

◆  Why extractable studies are not always representatives?

◆  How to deal with cumulative effect described in regulations?

◆  The concept of Lego approach to simplify cumulative evaluation?

◆  How to use of digital tool to support approach and simplify patient exposure scenario and toxicological evaluation?

GSK Vaccines, BE

◆  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.

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

◆  We will demonstrate the combination of the three detection techniques in one system to allow the concurrent measurement of UV absorption, Charged Aerosol Detection (CAD) signal and high resolution-accurate mass (HRAM) mass spectra from one injection.

◆  The inclusion of CAD detection provides complementary information to UV and HRMS, enabling more reliable semi-quantitation of non-chromophoric and non-volatile compounds.

◆  Several case studies will be shown with the application of this multi-detector approach in extractable studies of pharmaceutical packaging and medical device components. 

SGS Health Science, USA

◆  Composition of elastomers used for pharmaceutical applications.

◆  Material composition and extractables.

◆  How to minimize extractables/leachables from elastomeric closures.

West Pharmaceutical Services, USA, DE

◆  Agilent comprehensive portfolio to mitigate risk of E&L.

◆  Analytical Workflow strategies & Solution.

  • Scouting approach using modern molecular spectroscopy solution.
  • Identification & quantitation of E&L for volatile/ Semi-volatile Impurities using GCMS solution.
  • Streamlining Elemental Impurities, Extractables and Leachable Workflows Flow with Agilent Time Trap Analytical Solution.

Agilent Technologies Deutschland GmbH, DE

◆  What are the current drivers for Digital Transformation in Pharma?

◆  How is Pharma 4.0/5.0 defining the disruptive and transformative roadmap for more expedient operations, product development, advanced manufacturing, supply chain and lifecycle management?

◆  How are digital twins and cross-collaborative partnerships primary enablers for advanced manufacturing and digital transformation in pharma?

Eli Lilly, USA

Event Details