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Start time: 12:30pm GMT/ 1:30pm CET

Chair’s opening remarks
Session 1: Regulatory Updates
How will ICH Q3E support the study of extractables and leachables - the hope for better jam tomorrow?
  • Why is ICH guidance necessary? How should risk management be addressed?
  • Why leachables are perceived as different from other impurities and what thresholds should be put in place
  • Transparency, data integrity concerns, a shared glossary, and the limitations of analytical chemistry
  • Role of academic study to support E&L risk management

Jason Creasey | Managing Director & Principal Consultant, Maven E&L Ltd.
Concepts in leachable risk management – perspectives from ELSIE
ISO 10993 evolution: when 17 arrives after 18
  • Chemical characterisation of medical devices: ISO 10993-18:2020
  • Toxicological risk assessment: ISO 10993-17
  • New approaches in toxicological evaluation
  • In silico methods - case study

Paolo Pescio | ERT, HAS Consultant, Senior Scientific Director, Eurofins Medical Device Testing
Q&A Session
Session 2: Analytical Chemistry
Extractables and leachables analysis using a quadrupole time-of-flight (QTOF) mass spectrometer and SWATH acquisition
  • Using Independent Data Acquisition (SWATH) to obtain better information and better coverage of compound
  • Building a comprehensive library with MS/MS spectra for increasing the confidence in the identification

Jack Steed | Technical Specialist EMEAI, Sciex
Nitrosamine and GTI screening beyond generic screening methods
As shown in the Valsartan case, untargeted GC/MS resp. LC/MS impurity screening can detect significant amounts of GTI (ppm levels). However, for highly toxic GTI (nitrosamines e.g.) detection levels of 5-10 ppb are often requested, which exceeds capability of generic screening methods. The development of a nitrosamines specific test method, which detects 6 NDMA, NDEA, EIPNA, DPNA, DIPNA and NDBA in API/DP’s with an LOD of 10 ppb, will be presented. This method can be used to support risk assessments and confirmatory testing required by EMA/189634/2019.
Karl Abele | Senior Scientist, Solvias AG
APCI vs ESI – complementary or overlapping? A data review of organic compounds in E&L-studies
The two ionization techniques commonly used for LC-MS in E&L-studies are meant to be complementary and be able to identify unique compounds, covering a wider range of chemical compounds than used individually. After years of performing studies using both techniques, we have performed a data review to investigate how complementary they actually are in identifying extractables
Alfred Haglind | Scientist R&D, Cytiva
Extractables migration kinetic study under agitation conditions
  • Migration kinetic study design
  • Simulation study design
  • Predicting leachables
  • E&L study design

Ashley Hellenbrand | Associate Research Scientist, PPD Laboratories
Chair’s opening remarks
Session 3: Case Studies
Pro-electrophiles - a previously overlooked class of extractable with protein-reactive potential
  • Protein reactivity
  • Pro-electropiles
  • Screening assay
  • Aging of pro-electrophiles

Steven Watt | Business Development Manager, , A&M STABTEST Labor für Analytik und Stabilitätsprüfung GmbH
The toolbox for extrapolation of single use system extractables data towards process equipment related leachables
  • Extrapolation from extractables data to process conditions
  • Estimation of process equipment related leachbales (PERLs)
  • The use of basic physical methods for scaling and extrapolation
  • Justification of basic physical methods for scaling exercises
  • Comparison with experimental findings

Dr Armin Hauk | Principal Scientist, Sartorius Stedim Biotech GmbH
Extractable metals: potential sources in your packaging, risk management and change control
  • Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources, e.g. from plastic container materials
  • ICHQ3D outlines risk assessment of potential sources, container/closure system seen as potential origin of elemental impurities
  • Existing regulations (EP3.1, USP 661), with extractable tests covering only the 3-4 potential metals ‘expected’ in the particular polymer concerned. But is it enough?
  • Unconditional Change control is is fundamental to avoid unexpected contaminants in your packaging and risk to patient health

Cécile Balloffet | Business Development Manager, Healthcare Polymer Solutions, Avient Corporation (formerly Clariant Plastics & Coatings)
Regulatory challenges for biological evaluation of combination products
  • Considerations for reducing animal testing
  • Approaches for efficient chemical characterization
  • Potential strategies for biological evaluation

Dr. Cheryl Stults | Principal, C&M Technical Consulting
Session 4: Risk Assessments & Toxicology
Risk assessment for the need for leachables studies - industry guidance
  • Requirements for leachables studies
  • Risk based decision-making tool
  • PDA Technical Report #66 - Single Use System Qualification
  • ISPE Good Practice Guide for Disposables

Christopher Smalley | Compounding Pharmacist Advisor, ValSource
E&L safety assessment and best practice for PDE derivation
  • E&L safety assessment process as described in Broschard et al. (2016)
  • Overview of PDE Manuscript Parris et al. (2020)
  • Decision tree and case studies
  • Highlighting areas of uncertainty – where ELSIE is active to develop best practices

Patricia Parris | Global Risk Assessment Services Toxicologist, Drug Safety Research & Development, Global Regulatory , Pfizer
Panel discussion – Emerging toxicological issues for the safety assessment of E&L compounds
The process by which Health Based Exposure Limits (HBEL), like PDE and TI values, are derived for E&L compounds is undergoing a rapid evolution.  Although many well-accepted risk assessment approaches are currently being used to assess potential toxicological risks of E&L compounds, the unique challenges associated with the risk assessment of E&L compounds requires the development of creative fit-for-purpose methods to address these challenges.  An expert panel of toxicologists from the pharmaceutical and medical device sectors will explore these emerging approaches and will discuss best practices for implementing the new methods.   Topics to be addressed by the panel include:  the protectiveness of PDE and TI values for various local and systemic toxicological endpoints, the use of toxicity-based limits (e.g., TTC, SCT) to derive default PDE and TI values in the absence of compound-specific toxicity data, methods for route-to-route extrapolation of dose, and the use of existing regulatory limits for E&L compounds.  The goal of this session is to provide attendees with useful and practical advice for deriving PDE and TI values that will be accepted by regulatory agencies.

Ron Brown, Principal Toxicologist, Risk Science Consortium; US FDA (retired) ​

Panelists include
Patricia Parris, Global Risk Assessment Services Toxicologist, Drug Safety Research & Development Global Regulatory and Immunosafety Sciences, Pfizer
Dr Brad Stanard, Director, EHS Product Stewardship, Ultragenyx Pharmaceuticals
Elizabeth Martin, Strategic Impurities Toxicology Lead, Regulatory Safety Centre of Excellence, AstraZeneca
Joel M. Cohen, Senior Toxicologist, Gradient

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