3rd Annual Extractables & Leachables Summit 2023

Tentative Schedule:

Central European Summer Time (CEST, Prague, UTC/GMT +2 hour)

11:20 Opening Address

11:30 Challenge for Industry with new USP665/1665

• Risk Assessment Methodology (Upstream, Downstream process)
• Analysis of regulation and Requirements
• Key Challenge and experience from USP 1665

Isabelle Sbille,
Associate director- Material Safety Expert (E&L), UCB Biopharma SRL, Belgium

Pierre Van Durm,
Material of Contact global quality SME, UCB Biopharma SRL, Belgium

12:10 How to Improve the Accuracy of your E&L Testing

• ISO/IEC 17025 requirements, traceability and uncertainty
• Certification of relevant reference standards
• Intended use of CRMs, applications, and use cases
• Proficiency testing to improve your laboratory performance
• Compound databases for screening

Markus Obkircher,
Director R&D, Head of Reference Materials and Proficiency Testing, Merck, Sankt Gallen, Switzerland

12:50 To Be Announced

Jason Creasey,
Managing Director, Maven E&L Ltd, Stevenage, United Kingdom

13:30 Coffee break

13:50 To Be Announced

Erika Udovic,
Principal Scientist II, PCS Impurity Safety, Novartis, CH

14:30 To Be Announced

Atish Sen,
Director, Analytical Sciences Inhalation Product Development, AstraZeneca, North Carolina, United States

15:10 Toxicological Risk Assessment on Extractables and Leachables

• Introduction: why do we need to care about E&L?
• In silico assessment using computer expert systems
• Concept of Threshold of Toxicological Concern
• Concept of Permitted Daily Exposure
• Compounds of specific concern: nitrosamines

Dr. Clemens Günther,
Director Nonclinical Safety Consumer Care, Bayer AG, Berlin, Germany

15:50 Coffee break

16:10 How to Write a Toxicological Risk Assessment to Support Extractables and/or Leachables: A Step-by- Step Process

• Analytical identification of E&L compounds (tentative, definitive and unknowns)
• No toxicity data exists for your E&L compound: What to do?
• The E&L toxicology risk assessment process
• Derivation of maximum daily exposure (MDE) values
• Regulatory guidance as references for PDE values
• Toxicology databases to obtain toxicity data
• Selection of the point of departure to derive the PDE value

Dr. Greg Erexson, PhD, DABT, FATS, FRSB, ERT
AbbVie Retiree, Greg Erexson Toxicology Consulting, LLC, USA

16:50 Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTC) for Parenteral Extractables and Leachable

• The ELSIE consortium derived duration-based, non-mutagenic thresholds of toxicological concern (TTCs) for parenteral extractables and leachables substances.
• The first part of the presentation will provide a brief background on the ELSIE consortium and the ELSIE Risk Management Framework for extractables and leachable assessments.
• This will be followed by a general overview of the TTC concept and its application to mutagenic and non-mutagenic impurities.
• A majority of the presentation will then focus on the process for deriving the duration-based TTCs for parenteral E&Ls, including an overview of the ELSIE database, evaluation of the toxicological data used to determine the parenteral point of departuand application of adjustment factors.

Melisa Masuda-Herrera,
Senior Associate Scientist, Gilead Sciences, USA

17:30 PANEL DISCUSSION

Bram Jongen,
Vice President Materials & Surface Technologie, Datwyler Pharma Packaging International NV, Limburg, Belgium

Steve Zdravkovic,
Research Scientist II, Baxter International Inc., USA

Samuel N Kikandi, PhD,
Deputy Director-Principal Engineer/ Material Science & E&L SME, Sanofi, USA

Weifeng Lin,
Staff Scientist, Thermo Fisher Scientific, USA

18:10 Closing remarks and end of day two

Tentative Schedule:

Central European Time (CET, Prague, UTC/GMT +2 hour)

11:20 Opening Address

11:30 How to implement USP 665 requirements before 2026

The goal will be to present a lifecycle approach of our existing park of single-use, based on leachable risk, to ensure a compliance for the effectivity date of the USP in 2026.

• Management of existing items, lifecycle and retrospective approach
• Management of new items created between 2021 and 2026
• Ensure full compliance for items after 2026
• Quid of Chinese pharmacopea?

Marine Lepoutre,
Global Subject Matter Expert, GSK Vaccines, Belgium

Etienne Michel,
Global Quality Expert, GSK Vaccines, Belgium

12:10 Health risk assessment of Extractables and Leachables – things are not always what they seem

• Extractables and leachables (chemical characterisation) studies are a requirement for both medicines and medical devices.
• E&Ls can arise from containers and closure systems used for pharmaceuticals, from medical devices, and from packaging of both.
• Uncertainties exist in the characterisation of the source, identity and quantity of E&Ls, which can impact the toxicological risk assessment.
• This presentation will include several case studies of the toxicity assessment of E&Ls where these uncertainties were addressed.

Chris Waine,
Senior Toxicologist, bibra toxicology advice and consulting, UK

12:50 Case sharing of chemical characterization applications during the whole life cycle of Medical Devices

• Brief introduction to the application of chemical characterization
• Chemical characterization application for material selection
• Chemical characterization application for PCRB
• Chemical characterization application for NMPA registration

Wenjing Zhao ,
Sr Scientist, Medtronic Technology Center – Greater China, Shanghai, China

13:30 Coffee break

13:50 Leveraging Analytical Chemistry Data of Medical Devices to Derisk Drug Combination Product Submission

• Normative landscape around drug delivery systems development
• Challenges for defining the appropriate study design for upcoming of complex, highly sophisticated wearable systems
• Strategy proposal around potential standardization of test protocols in the context of Drug Combination Products

Delphine Brissaud,
R&D Staff Scientist, BD, FR

14:30 E&L studies from a Notified Body Perspective

• Importance of Chemical Characterization in the biological evaluation of medical devices
• E&L testing as part of the chemical characterization
• Importance of reporting thresholds
• Use of E&L data in addressing biological endpoints
• Life-time aspects in biological evaluation

Dr. Christina Reufsteck,
Biocompatibility Expert, TÜV SÜD Product Service GmbH, Germany

15:10 To Be Announced

Dr. Andreas Nixdorf,
Life Sciences - Business Development Manager Extractables & Leachables Testing, SGS Institut Fresenius GmbH, Frankfurt Am Main Area, Germany

15:50 Coffee break

16:10 Composition and shelf life considerations for the extractables profile of rubber

Dr. Tine Hardeman,
Manager Material Development Healthcare, Datwyler, Belgium

16:50 To Be Announced

Dennis Jenke,
Chief Executive Scientist, Triad Scientific Solutions, LLC, USA

17:30 ISO 10993-17 update.

Ron Brown
Owner and Principal Toxicologist, Risk Science Consortium, LLC, USA

18:10 To Be Announced

Jianfeng Hong,
Sr. Research Scientist, Fresenius Kabi, USA

18:50 Closing remarks and end of summit