Extractables & Leachables 2017 Agenda

See below for the program for E&L USA 2017

Tuesday 9th May

Pre-Conference Workshop

  1. Workshop: Leachable Risk Assessment: A structured approach to meet regulatory expectations

    Led by representatives from Smithers Rapra and GlaxoSmithKline

    The workshop will focus on leachable risk assessment and therefore a pre-read package on the basics of extractable and leachable with send to delegates in advance of this course, enabling the workshop to devote more time on the technical risk assessment process. The workshop is designed to give practical experience of performing a technical risk assessment to evaluate exposure risk to patients from leachables derived from container closure or manufacturing materials and then use extractable and/or leachable testing as risk reduction activities to meet regulatory expectations.

    It will consist of a mixture of short  presentations and predominately an interactive element performing a risk assessment on a fictitious medical product.  The facilitators from Smithers Rapra, Baxter Healthcare and GSK will assist in the workshop and give the presentations.

    The presentations will cover the concepts and themes associated with a science led risk based approach to extractable and leachable testing and its close alignment to concepts of quality by design and lifecycle management aligned to guidance of Drug Product Development (ICHQ8) and Quality Risk Management (ICHQ9).

    Interactive element will cover:

    • Risk identification (cause and effect)
    • Risk evaluation & analysis (knowledge gathering and scoring)
    • Risk reduction (Extractable and/or leachable testing)

    The workshop will cover the entire day and will include a light lunch. Please ensure you include your role in extractables and leachables when booking your ticket so teams can be assigned with a diverse mixture of people.

    Please note the workshop will run from 9.30am-5.30pm.

Wednesday 10th May

Wednesday 10 May

  1. Event Registration and Pre-Conference Networking

  2. Opening Remarks and Introduction from the Chairs

Regulatory policy updates

  1. Regulatory Perspectives for Dealing with Extractables and Leachables in Drugs

    Dr. Timothy Robison | Pharmacology and Toxicology Team Leader, CDER of FDA

Biocompatability and safety evaluation

  1. E&L and the Biocompatibility question – What’s Up?

    Dr. Cheryl Stults | Principal of C&M Technical Consulting

    • USP <1031> revision in process
    • Risk based approaches and testing paradigms
  2. A framework for the biocompatibility safety assessment of a transdermal drug delivery device

    Charles Ducker | Principal Chemist/Group Leader of Eurofins Medical Device Testing

    • A framework for the biocompatibility safety assessment of a drug delivery device and how extractables and leachables fit into this assessment.
    • Selection of biological assays to evaluate biocompatibility and in what order should they be conducted.
    • Novel design strategies to address the inherent challenges of evaluating biocompatibility of transdermal patches as per ISO 10993
  3. Networking Refreshment Break

  4. The challenges of developing PDEs for extractables

    Greg Erexson | Senior Principal Research Scientist of AbbVie

  5. In-Vitro toxicological evaluation of materials: The potential of using an AMES assay for the assessment of the mutagenic risk of extractables from the development of pharmaceutical containers

    Peter Cornelis | R&D Scientist and Business Development of Toxikon

  6. Networking Lunch


  1. Extractables and Leachables Laboratory Assessments: From Research Project to Commodity

    Dan Norwood, Executive Partner, SCIO Analyical and Kate Comstock, Senior Marketing Specialist, Thermo Fisher Scientific

  2. Ion-Mobility Mass Spectrometry and Screening Workflow for Detection and Identification of Extractables and Leachables

    Andrew Feilden, Chemistry Operations Director, Smithers Rapra and Naren Meruva, Principal Scientist, Waters Corporation

    • Challenges in positive identification
    • Improving confidence using scientific library
    • Advantages of ion mobility MS and CCS based workflow
  3. A Comprehensive Analytical Workflow for the Qualitative Assessment of Extractables and Leachables

    David Weil | Senior Application Scientist of Agilent Technologies

  4. Panel Discussion: Technology Advances for Extractables and Leachables Assessments

    Lead panellist: Daniel Norwood, Executive Partner, SCIO Analytical

    Kate Comstock, Senior Marketing Specialist, Thermo Fisher Scientific
    David Weil, Senior Application Scientist, Agilent Technologies
    Gyory Vas, Business Technical Scientific Liason, Intertek Pharmaceutical Services
    Kevin Rowland, Laboratory Manager, Jordi Labs
    Naren Meruva, Principal Scientist, Waters Corporation 

  5. Networking Refreshment Break

Advances in Science

  1. Bridging Extractables and Leachables – Mass Transport Modelling in Support of an Optimized Study Design

    Thomas Egert | Analytical Development of Boehringer Ingelheim Pharmaceuticals

  2. Interactions between leachables and pharmaceutical drug products – a myth or a fact?

    Carsten Worsøe | Principal Scientist Extractables and Leachables of Novo Nordisk

    Carsten Worsøe
    • Overview of interaction chemistry of leachables with drug products
    • Biological interactions
    • Typical interaction chemistry reactions and levels
    • Case studies
  3. Analytical assessments of degraded polymer products after Gamma sterilization and differences of extractables between before and after sterilization

    Motoshi Onoda | Research Chemist of Toray Research Center

    • Discoloration of polyolefin
    • Extractables of gum products before and after gamma sterilization
    • Deteriorated compounds of vulcanization accelerator
  4. The effect of solvent polarity modifiers and the extractables from HDPE, TPU, and PEBA resins

    Roger Pearson | President of Analytical Services of Aspen Research Corporation

    • Solvent polarity effect
    • Ethanol
    • IPA
    • Hexane

Thursday 11th May

Thursday 11 May

  1. Registration and Welcome Refreshments

E&L in biopharmaceutical manufacturing

  1. USP <665> Standard Extraction Protocol

    Dr. Dennis Jenke | Chief Executive Scientist of Triad Scientific Solutions

  2. Application of the BPOG Protocol for Standardized Extractables Testing in SUS: A case study for components used in Biomanufacturing

    James Mullis | Laboratory Manager, Extractables/Leachables and Trace Organic Analysis of PPD

    • The solvent systems used cover a wide range of polarities, pH conditions and solubilisation characteristics as directed by the BPOG
    • The data shows that the amount of organic extractables is a function of the extraction solvent system with the 50/50 Ethanol/Water producing greater numbers of compounds, while the more water based 5M NaCl produced the least number of compounds. Polysorbate 80 also produces a significant number of compounds; as a result of its ability to solubilize non-polar compounds in an aqueous solution
    • With the high and low pH solutions fewer compounds were extracted, but the solvents provide interesting consequences with the materials they come into contact with. For instance, high pH produces a large amount of Bisphenol A from polycarbonate, which is consistent with the nature of the composition of the polymer
  3. Networking Refreshment Break

  4. In Depth Characterization of E&L’s from Single Use Bioreactors, Data, Learnings and Perspective

    Jonathan Bones | Principal Investigator of National Institute for Bioprocessing Research and Training (NIBRT)

    • To focus the E&Ls approach from a biomanufacturing standpoint, since these compounds can adversely affect growth and viability of CHO cells
    • To develop a complete screening of E&Ls in single-use bags, in order to contribute with the existing databases
    • To develop sample preparation techniques and analytical methods for the determination of these compounds in process solutions (e.g. culture media)
    • To provide practical and versatile guidelines for the confident determination of these substances that would enable the early identification of non-satisfactory films, as well as control and improvement of single-use bags
  5. The fate of leachables during biotechnology drug substance downstream processing

    Michael Jahn | Head Forensic Chemistry, Drug Product Services of Lonza

    • Clearance of organic and elemental model compounds was investigated for mAb UF/DF and protein-A ALC
    • Clearance of organic model compounds was depending on their polarity (high clearance for polar compounds; low clearance for un-polar compounds). Elemental model compounds showed variable clearance
    • Theorethical predicton of clearance factors for downstream processing steps based on ideal clearance behaviour leads to too optimistic estimation of the fate of leachables
  6. A proactive approach to low extractables and leachables component selection for device development

    Ven Raman | Principal Scientist/Manager of MilliporeSigma (Merck)

    • Single use technology is no longer being adopted, it is the standard process technology
    • Extractables and leachables from single use components are one of the most significant concerns end users have regarding its implementation
    • Vendors with a good understanding of the end use of their products can make conscientious raw material choices that can alleviate many issues/concerns
  7. Networking Lunch

  8. Standardized extractables testing of single use systems: An overview of sterile filter extractables

    Ina Pahl | Senior Scientist of R&D of Sartorius Stedim

    • Present a standardized and validated methodology to investigate extractables from SUS used in bio-pharmaceutical processes
    • The capability of the method will be demonstrated for filter devices
    • Qualitative and quantitative data will be presented on typical extractables released from modern state-of-the-art sterile filters on the market
    • The potential load of leachables in a generic process associated with filtration steps will be discussed
  9. Insights into the BPOG and USP <665> Process Contact Testing Requirements

    Raymond Colton | Founder and President of VR Analytical

    Both the USP and BPOG have recommended protocols for extractable testing for product contact materials including single use systems (SUS).  This presentation compares the two test regimens using sterile filters and then presents additional test results that were performed to explain some of the unexpected differences in the results.  

Packaging and Delivery Systems

  1. Analytical Assessment for Packaging Components Made from Recycled Materials

    Gyorgy Vas | Business Technical Scientific Liaison of Intertek

    • Recycled materials
    • Polynuclear aromatics
    • GC-MS/MS
    • Parts per trillion level testing
  2. <661.1> and <661.2>

    Desmond Hunt | Principal Scientific Liason of U.S. Pharmacopeial Convention (USP)

  3. Chair Closing Remarks