2019 Agenda

Tuesday 12 November

Pre-conference workshop

  1. Registration and welcome refreshments

  2. Introduction to Extractables and Leachables workshop

    Workshop led by Dr. Andrew Feilden, Chemistry Operations Director and Tim Hulme, Principal Consultant, Smithers Rapra, UK

    Smither

    Workshop information:

    Introduction to Extractables and leachables:     
    Definition of extractables and leachables
    Why are they important
    Regulatory standpoints and requirements
    Working groups and guidance documents
    Determination of limits

    Material selection:
    Discussion of polymeric and elastomeric materials
    Polymer additives, potential impurities and the reasons for their presence.
    Review of supply chain
    Factors affecting the migration of compounds         

    11:00 - 11:30 Morning networking break 

    Risk assessment
    BPOG,
    USP 665
     
    Extraction techniques
    Component review & selection of critical parts
    Aim of extractable study
    Extraction methods, including solvent choice and sample preparation techniques.

    13:00 - 14:00 Light lunch 

    Analytical Techniques
    What techniques are required
    Starting points for methods

    15:30 - 16:00 Afternoon networking break

    Leachable Method Development & Validation:                               
    Leachable method development
    Selection of extractable / leachable compounds
    Development of leachable analytical methods
    Leachable method validation
    Leachable studies
    Stability storage overview
    Leachable time point analysis

    17:30 Workshop ends

    Tickets are just £799 in addition to your 2-day conference ticket. Places are limited so we advise booking as soon as possible to avoid missing out!

    Please note, you must book (or have already booked) an Extractables & Leachables Europe 2019 conference ticket in order to attend the workshop.

  3. Workshop ends

Wednesday 13 November

Wednesday 13 November

  1. Registration and welcome refreshment

  2. Chair’s opening remarks

Session 1 – Regulatory landscape, requirements and strategies for E&L studies

  1. Drug product leachable study survey results

    Ken Wong | Deputy Director of Sanofi Pasteur, USA

  2. Update of the USP chapters related to E&L’s– finalisation of USP <665> and <1665> and update of USP <661> and <1661>

    Dr. Michael Eakins | Founder and Principal Consultant of Eakins and Associates

  3. BPOG E&L SUS – the final chapter

    Sara Ullsten, R&D Section Manager, GE Health Care, Sweden and Carsten Worsøe, Principal Scientist Extractables and Leachables, Novo Nordisk, Denmark and Sam Denby Facilitator, BioPhorum Operations Group, UK

    • Supplier and end-user collaboration
    • Extractables ecosystem
    • Data review process
    • Extractables protocol update
    • Community of practice
  4. Networking refreshments break

  5. U.S. FDA Biocompability device chemical and safety assessment perspective

    Berk Oktem | Chemist of U.S. FDA, USA

  6. Panel and Q&A session

Session 2 - Methods to assess the toxicity of E&L compounds

  1. Transformation of toxicology data into specific PDE’s

    Kim Li | Senior Manager Environment, Health, Safety and Sustainability of Amgen Inc., USA

  2. The potential for screening of toxic components in pharmaceutical products

    Tom Van Wick | Principal Scientist of Abbott

  3. Networking lunch

  4. Sensitisation risk assessment - considerations and approaches

    Patricia Parris | Project Toxicologist of AstraZeneca, UK

    • Highlight the challenges in qualifying sensitisation safety endpoint for E&Ls.
    • Current approaches for assessing systemic sensitisation including product quality Research Institute (PQRI). recommendations and other relevant safety limits such as Dermal Sensitisation Threshold or Cramer.
    • Extractables and leachables safety information exchange (ELSIE) initiative that is ongoing to further develop a strategy for evaluating sensitization risk.
    • Describe how the established adverse outcome pathway for sensitisation developed in the cosmetics industry and could be adapted for E&Ls in pharmaceutical and drug-device products.
  5. Leachables and extractables degradation products: it can always get worse

    Thomas Broschard | Associate Director, Head of Chemical Toxicology of Merck KGaA, Germany

  6. The need to identify unknown E&Ls from a risk assessment perspective

    Ronald Brown | Toxicologist of former U.S. FDA (retired)

  7. Networking refreshments break

Session 3 - E&L study strategies and characterisation of unknown E&L’s

  1. Approaches to simulated leachable studies; What are they? When do them?

    Jason Creasey | Director of GSK, UK

    • How are they different from Extractable or Leachables Studies?
    • What type of dose form might they be best suited for?
    • An example simulated study application
  2. Use of HRAM MS and advanced data processing in extraction studies of complex polymeric materials

    Asger Wisti Nørgaard | Senior Research Scientist of Novo Nordisk, Denmark

    • High resolution accurate mass (HRAM) LCMS analysis using data dependent MS2
    • Automated data processing
    • Identification of unknown compounds – what if your analytes are not in the library?
    • Case studies: Identification of unknown extractables/leachables
  3. Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence?

    Petra Booij | Investigator of GlaxoSmithKline, UK

    • Approach for more effective identification of extractables and leachables using mass spectrometry
    • Set-up and maintenance requirements for spectral libraries
    • Levels of confirmation of identified extractables and leachables
  4. Unknown E&L Q&A session

  5. Chair’s conference summary and closing remarks

Thursday 14 November

Thursday 14 November

  1. Registration and welcome refreshments

  2. Chair’s opening remarks

Session 4 - Effect of E&Ls on the safety and efficacy of proteins, biopharmaceuticals, and cell-based therapies

  1. Extractable data mining: common extractables from polymeric manufacturing materials used in biologics production

    Ping Wang | Scientific Director of Janssen R&D, USA

    • Safety assessment of extractables and leachables is often based on assumption that E&L are highly toxic
    • Most common extractables from about 40 sets of study data indicates that none of them is part of “cohort of concern” per ICH M7 guideline.
    • Safety profiles of common extractables from common single use systems can be used to design a risk-based approach for future materials.
  2. Assessing the risk of interaction between extractables and leachables (E&L) and therapeutic proteins

    Andrew Teasdale | Senior Principal Scientist Impurity Management and External Advocacy of AstraZeneca, UK

  3. Extractable and leachable testing of cell & gene therapy (CGT) products – case study highlighting critical aspects of study design, testing and reporting

    Nick Morley | Principal Scientist of Hall Analytical Laboratories

  4. Q&A session

Session 5 - Medical device and combination products

  1. Devices ISO 10993 part 17/ 18 on chemical characterisation

    Jeremy Tinkler | Director of Regulatory Consultancy and Quality Assurance of MedPass International, France

  2. Networking break including poster session. Attend the poster session to find out about cutting-edge E&L science and put your questions to the authors

    Further information to be announced...

  3. Toxicological assessment of extractables and leachables from medical devices and combination products in the biopharmaceutical industry

    Dr. Nina Macho | Scientist Pharmacology and Toxicology of Octapharma, Austria

  4. Extractables and leachables study for a drug - device combination product: a success case study

    Ashley Hellenbrand | Associate Group Leader of PPD Ireland (Athlone GMP lab), Irland

  5. Panel and Q&A session

  6. Networking lunch

Session 6 - Suppliers perspective

  1. Win: win approach to USP <665> and BPOG extractables requirements for all polymeric components, enabling QbD selection and qualification of multicomponent single use systems

    James Hathcock | Senior Director, Regulatory and Validation of Pall Biotech, USA

    • Simple supplier approach and examples to provision of <665>, BPOG and application-specific extractables data
    • Addressing ambiguities in supplier- vs end-user perceived component risk
    • Example of supporting data and risk assessment for a single use, continuous bioprocessManaging change control in the era of BPOG, USP <665>, and other specific application requirementsManaging consistency and quality of component extractables data across multiple suppliers and test labs
  2. Case study

    Speaker to be confirmed

Session 7 - Computational approaches to predict the release of E&L from polymeric materials

  1. Physics-based model to predict patient exposure to polymer additives in medical device materials

    David Saylor | Research Materials Engineer of Food and Drug Administration, USA

  2. Pre-experimental Information for plastic materials suitability Assessments

    Thomas Egert | Analytical Development of Boehringer Ingelheim Pharmaceuticals, Germany

  3. Chair’s conference summary and closing remarks

  4. End of conference