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

  • Aerosol-based detectors (CAD) as a solution to analytical challenges in the evaluation of E&L: troubleshooting and practical answers.
  • How to implement effective E&L study designs.
  • Risk assessing extractables and leachables in topical ophthalmic drugs: case studies and lessons learnt.
  • ELSIE’s Lab Practices Working Group’s Proposal for Best Practices to Improve the Consistency of Extractable Screening Data Between Laboratories.
  • Toxicological Risk Assessment on Extractables and Leachables.
  • Safety assessment of E&Ls: toxicology assessment workflow and challenges with different administration routes.
  • Read-across and route-to-route extrapolation in toxicological risk assessment of E&L.
  • Effect of X-ray vs. gamma on the extractables profile of rubber closures.
  • E&L assessment of biologic drug products.
  • E&L testing for medical devices.
  • Aligning expectations and risk assessment strategies for bioprocess equipment.
  • Testing for E&L in packaging materials.
  • Extractables testing of Single Use Systems (SUS).

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
Sam Albeke
Chromatography Manager
Element Materials Technology
Eric Hill
Chief Scientific Officer
BA Sciences
James Hathcock
Sr Director, Regulatory and Validation Strategy
Cytiva
Dvir Doron
Director, Chemical Toxicology Team Leader
Teva Pharmaceutical Industries Ltd.
Will Parker
E&L Technology Manager
West Pharmaceutical Services
Ana Kuschel
Principal Scientific Affairs
West Pharmaceutical Services
Katherine Lovejoy
Application Chemist
Thermo Fisher Scientific
Divya Regulagedda
Manager (Global SME)
Chemo Group
Erika Udovic
Senior Principal Scientist
Novartis Pharma AG
Dujuan Lu
E&L Manager/Global Leader
SGS Health Science
Tine Hardeman
Manager Material Development
Datwyler
Steve Zdravkovic
Research Scientist II
Baxter Healthcare
Etienne Michel
Global QA for E&L
GSK Vaccines
Marine Lepoutre
E&L Global SME
GSK Vaccines
Reinhard Stidl
Senior Toxicologist - Managing Director
Safetree Consulting e.U.
Clemens Guenther
Former Senior Expert Nonclinical Safety at Bayer AG
Independent Lecturer

Summit Agenda

◆  Sample preparation, extraction studies and quantification.

◆  Classifying and identifying targeted substances.

◆  Risk assessment and profiling for extractables.

◆  Assessment of stability studies and leachables.

◆  E&L originating directly from the LDPE bottle vs. adducts between the active ingredient and LDPE bottle components (secondary leachables): regulatory perspective.

◆  Application of PQRI principles and the FDA draft guidance for industry on quality considerations for topical ophthalmic drug products: key toxicity endpoints and safety thresholds.

◆  Evaluation of dermal and systemic sensitization of E&L based on the ELSIE framework.

◆  Utilization of in silico (Q)SAR methods in the absence of experimental data.

◆  Sponsoring the event is a great way to introduce your brand to an interested audience.

◆  You can find sponsorship options on the Sponsorship page

◆  To book and secure a package - please send back a scan copy (or electronic version with electronic signature) of the registration form with your details (last page of the agenda). It is also possible to register directly via the Website.

◆  The moment you book a package your info will be added to the brochure which is being distributed within our network and through our marketing channels.

◆  To learn more, contact us info@uventia.com

◆ Inconsistencies in the execution of extractable screening studies between laboratories can result in differences in the qualitative and/or quantitative aspects of the extractable profiles obtained.

◆ Given that such differences can have a significant impact on the validity of the safety assessments performed, it is critical that they be understood and minimized.

◆ The “lab practices” working group within the Extractable/Leachable Safety Information Exchange (ELSIE) conducted two industry surveys that uncovered numerous areas associated with the execution of extractable screening studies where labs were not well aligned that may be impacting the data generated.

◆ To that end, this presentation will summarize the best practice recommendations proposed by the ELSIE lab practices working group to address the discrepancies in extractable study design.

◆  Introduction: why do we need to care about E&L?

◆  How to perform a Toxicological Risk Assessment.

◆  The concept of Permitted Daily Exposure (PDE).

◆  The concept of Threshold of Toxicological Concern (TTC).

◆  Compounds of specific concern: Nitrosamines.

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

◆ Considerations for different administration routes, including (topical) ocular.

◆  Read-across – a tox assessment strategy for data poor substances.

◆  Tools and justification paths for read-across.

◆  Standardized method for extrapolation from oral to parenteral route of administration.

◆  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.

The goal will be to present how to effectively handle additional new requirements in parallel with USP 665 (including USP 661.1, 661.2, 662, 382, 383, and EP 4.2.35) and transition from strategy to a fully implemented and operational USP 665 compliance program.
Strategy Program: From Presentation to Implementation:

◆  Key Learnings: Insights gained from the transition of the strategy program from its presentation at the previous conference to its current implementation and usage.

◆  Key Difficulties Faced During Implementation: Challenges encountered while putting the strategy program into practice.

◆  Management of Labs and Testing: Approaches and methods used to manage laboratory operations and testing procedures.

◆  Workload Management: Strategies employed to handle and distribute workload effectively.

◆  Digitalization as a Key Element: The role of digitalization in enhancing the efficiency and effectiveness of the strategy program.

◆  Managing Additional Requirements in Terms of E&L: How to address and incorporate additional requirements related to Extractables and Leachables (E&L).

◆  Additional Testing for Cured Silicone Elastomers (USP 383): Specific testing protocols for cured silicone elastomers as per USP 383 standards.

◆  Plastic Packaging Systems vs. Physicochemical Testing (USP 661.2): Comparison between plastic packaging systems and physicochemical testing requirements outlined in USP 661.2.

◆  Glass Container Requirements in Terms of Extractables (Future USP 660): Anticipated requirements for glass containers concerning extractables, as per the upcoming USP 660 standards.

◆  Metallic Packaging Systems (USP 662): Standards and testing requirements for metallic packaging systems according to USP 662.

◆  Combined targeted quantitation and non-targeted screening for PFAS during a single analysis.

◆  One LC-MS method providing both PFAS-specific and general extractables screening.

◆  Targeted analysis of a list of PFAS to yield unequivocal identification and quantification down to sub-ppb levels.

◆  Non-targeted analysis to reveal additional PFAS contaminants in the sample extracts that can be quantified using surrogate standards.

◆  Use of the PFAS analysis kit and delay column to minimize background interference and increase confidence in the analytical results.

◆  What is needed and what is not. Updated overview of standards relevant to bioprocess resk assessment and qualification.

◆  Case study examples of different single-use applications, supporting data, and risk assessment.

◆  Clearance of PERLS in lipid nanoparticle genomic medicines as well as traditional biologics manufacturing processes.

Cytiva, USA

◆  Reviewing USP packaging criteria.

◆ Relating chemical characterisation of components.

◆  E&L examination of glass, plastic and elastomer components.

◆  In the rapidly advancing field of Cell & Gene Therapy (CGT) manufacturing, the use of single-use processing components is integral for efficiency and flexibility. Fluoropolymers, such as FEP, have been commonly used as materials of construction for these components and commonly known for being inert. However, concerns have emerged regarding the potential migration of Per- and Polyfluoroalkyl Substances (PFAS) from fluoropolymer contact materials into therapeutic products. When PFAS are detected in E&L studies, they require thorough investigation to ensure the safety and efficacy of CGT products.

◆  This presentation will dive into a case study for the identification of PFAS from a commonly used single-use material, FEP. The case study will cover factors influencing migration, potential impacts on patient safety and regulatory feedback received with regards to PFA detection in CGT E&L studies. This presentation seeks to facilitate a collaborative dialogue within the CGT community, fostering awareness, and encouraging the development of industry-wide standards to ensure the continued success and safety of Cell & Gene Therapy products.

Event Details