2nd Annual Extractables & Leachables Summit 2022 - uventia

2nd Annual Extractables & Leachables Summit 2022

2nd Annual Extractables Leachables Summit
Event Details


Extractables and leachables (E&L) assessment is a critical part in product development strategy. Regulatory bodies are very concerned about the interaction between pharmaceutical products and container closure systems, drug delivery devices, as well bioprocess manufacturing systems. Therefore, the migration of mobile chemicals from components and ingredients used in drug production and storage needs to be carefully evaluated.

Our online conference brings together scientists, toxicologists and managers to share the latest E&L analytical methods and strategies, regulatory updates and compliance, risk-based E&L programs, chemical characterization and toxicological risk assessment, material selection/screening/identification, uncertainty factors in E&L testing, analytical and safety thresholds, medical device materials and ISO 10993-18, customized methods for specific product types.

Participate in our virtual meeting and equip yourself with new tools to analyze and test for extractables and leachables in biopharmaceutical development - to effectively reduce E&L-related risks and ensure patient safety and product quality.


  • The toxicological risk assessment for extractables & leachables.
  • Derivation of permitted daily exposure limits for individual or groups of E&L substances.
  • Identification and sensitivity issues during E&L studies – possible solutions and workarounds.
  • Designing effective E&L studies.
  • E&L programs to balance costs and turnaround time.
  • Emerging data visualization approaches for rapid, heuristic interpretation of highly complex mixtures of structurally and compositionally diverse chemical entities associated with E&L and pharmaceutically relevant materials.
  • Challenges in therapeutic biological products.
  • Extractables of membrane sterile filters – identification, lessons learned and rinsing recommendation.
  • Similarities and differences between medicinal products and medical devices for extractable and leachable testing.
  • E&L risk assessment in bioprocess manufacturing systems.
  • PQRI E&L thresholds.
  • How to construct a quality risk assessment to define E&L requirements for sus in parenteral processes?
  • E&L testing for packaging materials.


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] 2nd Annual Extractables & Leachables Summit 2022

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 Event

● 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.

● AbbVie, Inc. ● Albhades Provence ● Altran ● AryoGen Pharmed ● AstraZeneca ● B. Braun Medical AG ● Bayer AG ● Bio-Technology General (Israel) Ltd. / Ferring Pharmaceuticals ● Biogen ● Boehringer Ingelheim ● Butterworth Laboratories Ltd ● Carso ● Cenexi ● Chemo SA ● Chiesi Farmaceutici spa ● CMIC Pharma Science Co.,Ltd. ● Constantia Patz Ges.m.b.H. ● ConvaTec ● CSL Behring AG ● ELPEN Pharmaceutical Co. Inc. ● GSK ● GSK Vaccines ● Hall Analytical ● Illumina ● Imperial Brands ● Incyte ● Intertek (Schweiz) AG ● Intervenance NG ● Jagiellońskie Centrum Innowacji ● Laboratorio Reig Jofre, S.A. ● Lonza ● Lonza DPS ● Medtronic LTD. ● Merck Healthcare KGaA ● Merck Serono ● Microvention Inc. ● Minapharm Pharmaceuticals ● National Institute for Bioprocessing Research and Training (NIBRT) ● Nelson Labs Europe ● NNE ● Norner AS ● Novartis ● Octapharma ● Pharma Quality Europe srl ● PHARMA-DATA S.A. ● Polpharma ● ProPharma Group ● Regeneron ● S&C BEST Srl ● SaniSure ● SCIEX ● SGD Pharma ● Solvias AG ● Swissmedic ● Synthon Hispania ● Takeda ● Takeda Pharmaceuticals ● Taro Pharmaceuticals inc. ● Teva Pharmaceuticals ● UAB Teva Baltics ● UCB Biopharma SRL ● Viatris ● Waters Corporation ● Watson-Marlow Fluid Technology Group ● WuXi Biologics ● Xellia Pharmaceuticals

Speaker Board
Paolo Grisostomi
Sr. Engineer, Materials Science
Douglas Kiehl
Research Advisor
Eli Lilly
Frances Sexton
Consultant Scientist
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
Wei Zhang
Manager, QC Analytical Sciences
Diane Paskiet
Director – Scientific Affairs
West Pharma
Roberto Menzel
Head of Extractables Laboratory
Reinhard Stidl
Senior Toxicologist - Managing Director
Safetree Consulting e.U.
Tino Otte
Head of Sales and Consulting
Intertek (Schweiz) AG
Clemens Guenther
Director, Senior Expert Nonclinical Safety
Bayer AG
Andrew Feilden
European E&L Strategic Director
Bicycle Therapeutics
Atish Sen
Staff Scientist

Summit Agenda

◆  Step 1: The planning phase.

◆  Analytical and safety thresholds.

◆  Assessing toxicological risk and evaluating toxicological information.

Bayer AG, DE

◆  Standardized approach for PDE derivation.

◆  Use of surrogate data for data poor substances.

◆  In silico tools to cover essential endpoints.

◆  Case studies.

Safetree Consulting e.U., AT

Sensitivity issues or the presence of analytes with unidentifiable structure are typical problems during many E&L studies. Case studies and possible solutions are discussed:

◆  Reasons for presence of unknown compounds and insufficient sensitivity.

◆  Optimization of the study design to reduce the risks.

◆  How to use E&L data even if sensitivity is not sufficient.

◆  Approaches for direct and indirect identification.

◆  Leachable or matrix artefacts: Approaches to assess the origin of unknown compounds.

Intertek (Schweiz) AG, CH

◆  Sample preparation considerations for screening studies.

◆  Compound identification and classification.

◆  Understanding and accounting for the impact of analytical variation on data from screening studies.

◆  Using targeted analytical methodologies to monitor leachables over a product‘s lifetime.

Baxter Healthcare, USA

◆  Aim to build an expandable and resilient E&L risk management system.

◆  Incorporate E&L risk assessment into cross-functional quality management systems.

◆  Implement effective risk mitigation strategies to tackle E&L challenges in a time of change.

Regeneron, USA

◆  Challenges with establishing comprehensive profiles from complex mixtures of diverse extractables.

◆  Data visualization/AI approaches to enable heuristic complex mixture data interpretation.

◆  Potential applications in modeling/simulation, rapid decision making and change management.

Eli Lilly, USA

◆  E&L challenges for large-molecules and Therapeutic Biological Products.

◆  Impact of E&L for biologics product.

◆  Risk for biological drug substance and drug products, and mitigations.

Biogen, CH

◆  How to simply filter device Extractables identification through material knowledge.

◆  Discussion of the missing links to improve the completness of screening studies – TOC ‚reconcilaition‘.

◆  Case study to identify the last unknown.

◆  Relevance of rinsing in biopharmaceutical applications.

Sartorius, DE

◆  What are medical devices.

◆  What are the key challanges achieving chemical characterisation.

◆  The role of uncertainty factors in determining levels.

Bicycle Therapeutics, UK

◆  Where to start and what are the basics for risk assessing for bioprocessing.

◆  Best practices and changing environment.

◆  Where does the risk lie?

Eli Lilly, IE

◆  Summary of PQRI PDP Recommendations.

◆  Analytical Evaluation Thresholds (AET) Application & Challenges.

◆  E&L Studies and Data Correlations.

West Pharmaceutical Services Inc., USA

◆  Advantages / Risks of SUS.

◆  Balance between Fixed Equiment & SUS and regulatory evolution.

◆  Leachable Risk assessment: steps, methodology and associated testing requirements.

◆  Open discussion and conclusion on E&L requirements.

GSK Vaccines, BE

◆  Review of packaging regulations and standards.

◆  Assessment and testing packaging materials.

◆  Lifecycle management of packaging materials.

AstraZeneca, USA

Event Details