5th Annual Extractables & Leachables Summit 2025 - uventia

5th Annual Extractables & Leachables Summit 2025

Event Details

CONFERENCE OVERVIEW

The assessment of extractables and leachables is a critical step in the biopharmaceutical development process. The interactions between pharmaceutical products and drug delivery systems, bioprocess manufacturing systems, and container closing systems are of special concern for regulatory bodies. Therefore, it is necessary to carefully examine the migration of mobile molecules from the materials and components utilized in the production and storage of pharmaceuticals.

We organize a virtual conference to facilitate discussion on the most recent analytical techniques, regulatory updates, risk-based E&L programs, chemical characterization and toxicological risk assessment among scientists, toxicologists and E&L managers. We also cover ISO 10993-18, medical device materials, analytical and safety thresholds and customized systems for different product types.

Participate in our event to learn about the latest methods for testing and analyzing extractables and leachables. This can help you significantly reduce the risks associated with E&L while also assuring patient safety and product quality.

WE WILL TALK ABOUT

  • Leachables and extractables as an essential component of product development and launch.
  • Accurate analytical methods for the identification, measurement, and screening of E&L compounds.
  • Exchanging knowledge from experts about how to plan, execute and publish E&L studies.
  • Examining revisions to regulations to keep regulatory approvals compliant and cost-effective.
  • Industry guidelines for toxicological risk assessment and chemical characterization.
  • Comprehensive E&L evaluations for complex materials, products and processes.

WHO IS IT FOR?

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] 5th Annual Extractables & Leachables Summit 2025

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

Speaker Board
Will Parker
E&L Technology Manager
West Pharmaceutical Services
Ana Kuschel
Principal Scientific Affairs
West Pharmaceutical Services
Erika Udovic
Senior Principal Scientist
Novartis Pharma AG
Dujuan Lu
E&L Manager/Global Leader
SGS Health Science
Tine Hardeman
Manager Material Development
Datwyler
Clemens Guenther
Former Senior Expert Nonclinical Safety
Bayer AG

Summit Agenda

◆  Regulatory criteria for pharmaceuticals and medical devices.

◆  How are the E&L data viewed by EMA and FDA?

◆  E&L testing recommendations from PQRI, ICH, and USP.

◆  Early integration of E&L studies into pharma product development.

◆  Employing efficient risk-management strategies.

◆  Digital transformation and its impact on E&L assessment.

◆  Sample preparation, extraction studies and quantification.

◆  Classifying and identifying targeted substances.

◆  Risk assessment and profiling for extractables.

◆  Assessment of stability studies and leachables.

◆  The selection and validation of analytical techniques.

◆  Minimizing the impact of uncertainty on E&L testing.

◆  Restricting the response factor variation in E&L analysis.

◆  Tips for choosing an analytical partner.

◆  How to process, report and visualize E&L data.

◆  Improving data integrity.

◆  Identifying unknown compounds.

◆  Submitting E&L data to the regulator.

◆  PQRI’s recommendations for analytical and safety thresholds.

◆  The QSAR application and qualification standards.

◆  Analyzing toxicological risk and toxicity data.

◆  Concerns for large-molecule parenteral formulations.

◆  E&L testing for biopharmaceutical packaging systems.

◆  Considerations while manufacturing biological drugs.

◆  Investigation towards the effect of X-ray irradiation on the extractables profile of rubber closures.

◆  Comparison of X-ray irradiation with gamma irradiation and their effect on extractables.

◆  Changes in the extractables profiles of rubber closures at the end of shelf life.

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

◆  Evaluation of biocompatibility and toxicological risk.

◆  The verification of analytical methods.

◆  Handling leachables originated from manufacturing.

◆  Addressing issues with disposable technology.

◆  USP-compliant testing to qualify materials.

◆  Qualification of SUS materials.

◆  Single-use systems and BPOG.

◆  Customized techniques for SUS analysis.

◆  Unique challenges with E&L studies for CGTs.

◆  Analyzing E&L risks in plans for product development.

◆  Studies on simulation and material characterization.

◆  Data analysis and toxicological assessment.

Event Details