Event Agenda

Below is the 2016 Agenda outlining speakers and topics discussed at the 10th Annual Extractables & Leachables conference in Dublin.

Tuesday 8 November

Tuesday 8 November

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

    Led by representatives from Smithers Rapra, Baxter Healthcare 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.

    To find out more: click here.

    *Please note, if you register to attend the workshop you will be unable to attend the site visit to NIBRT.

    Finishes at 5.30pm.

  2. Site Visit: NIBRT

    To celebrate the 10th anniversary of Extractables & Leachables Europe, we'll be visiting NIBRT's Dublin facility. This is the first time ever that a site visit has taken place as part of the E&L Europe conference!

    Taking place before the 2-day conference on Tuesday 8th November 2016 from 14:00 - 17:00, this is the perfect way to kick off your Extractables & Leachables conference experience.

    As part of the site visit, participants will take part in an interactive tour of the bioprocessing pilot plant, with access to all production areas.  This will give visitors a good understanding of the process flow and the equipment involved in the bioprocessing industry. 

    The site visit will include a light lunch.

    To find out more: click here.

    *Please note, if you register to attend the site visit to NIBRT you will be unable to attend the workshop.

    Finishes at 5.30pm

  3. Close of Pre-Conference Day

Wednesday 9 November

Wednesday 9 November

  1. Event Registration and Pre-Conference Networking

  2. Opening Remarks and Introduction from the Chairs

    Andrew Feilden, Chemistry Operations Director, Smithers Rapra and Carsten Worsoe, Principal Scientist Extractables and Leachables, Novo Nordisk

Regulations and Working Group Updates

  1. European Regulatory Perspective on Extractables and Leachables

    Karin Bracht | Senior Pharmaceutical Assessor of MHRA

  2. E&L Challenges of An In Licensed Product and Aligning to Current Guidance

    Kevin Day | Associate Principal Scientist of AstraZeneca

E&L Chemistry

  1. Examples of Real World Extractable and Leachable Study Data

    Malcolm Kimber | Laboratory Operations Director of Hall Analytical Laboratories

  2. Networking Refreshment Break

  3. Simplifying the Detection of Known Components using a New Commercially Available E&L Accurate-Mass Database and MS/MS Library

    Gordon Ross and David Weil, Agilent Technologies

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

    Carsten Worsøe | Principal Scientist Extractables and Leachables of Novo Nordisk

    Carsten Worsøe
    • Interactions between leachables and drug products
    • Health authorities interest in biological interaction products
    • Cases of interactions observed in drug products
  5. Protein-Reactive Extractables: A Screening Assay Which Adds Additional Value to the Traditional E/L Workflow

    Steven Watts | Business Development Manager of A&M STABTEST

    • Is an AET guided approach to extraction studies valid for protein-reactive leachables?
    • Chemical modifications to single amino acids of a biological in extreme cases may cause adverse effects such as immunological response, but at least diminish product quality
    • We propose a screening approach using model substrates similar to the OCED TG442C guideline for testing in-chemico skin sensitation
    • First results of an LC-MS screening study with different rubber stopper extracts indicate different propensity of different materials to potentially modify amino acids in proteins
    • Give a summary of the different extractable reactants and the reaction products formed
    • We believe that the proposed screening is a valuable addition to the “holistic E&L program” suggested by Li et. Al.   
  6. Networking Lunch

Materials Supply Chain and Case Studies

  1. Raw Material Management and Product Deisgn Strategy For Enhanced Quality, Assurance of Supply, Validation & Change Control of Single-Use Systems

    Luke Heaven | Director of Marketing for Fluid Management Technologies of Sartorius Stedim

  2. Compliance Is Not Enough: The Journey of a Polymer Producer to Support Customer E&L Needs

    Jerome Vachon | Lead Scientist in the Materials Science of SABIC

    • SABIC presentation and views with respect to Healthcare market
    • Extractables experimental procedure selection (solvent, analytical techniquest, LOD)
    • Key learnings on additives and NIAS from own grades
    • Sterilisation study (gamma radiation) on a HDPE and LDPE grade
  3. Networking Refreshment Break

  4. Inner barrier coating prevents contamination of drug products with potential impurities from primary containers composed of COP, a case study

    Sigrid Saaler-Reinhardt, Director Corporate Project Management, Midas Pharma with Christopher Weikart, Chief Scientist, Si02 Medical Products

    • E&L data of a drug product submission in Europe
    • Features of inner barrier coating that prevent contamination from COP
    • Regulatory requirements: Case study Zoledronic acid
  5. Mathematical Modeling of the Extractables Release from Ink Label Printed Directly on Plastic Films Used in Drug Product Containers

    Francois Bianchi | Head of Global Packaging Migration of B.Braun Medical

    • Use of advanced finite element Analysis (FEA) migration modelling for E&L
    • Application in label ink design and risk mitigation for large volume semi-rigid packaging system
  6. Examination of Cure Time, Sterilization and Formulation Process Variables on Extractables and Leachables from Medical Device Componentry

    Alan Hendricker | Manager - Chemical Sciences of Becton Dickinson

    • Medical devices
    • Mass spectrometry
    • ISO-10993
    • Materials Selection best practices
    • Change control
  7. Panel Discussion: Risk Assessments: How to make best use of them

    Panellists TBC

  8. Chair Closing Remarks

    Andrew Feilden, Chemistry Operations Director, Smithers Rapra and Carsten Worsoe, Principal Scientist Extractables and Leachables, Novo Nordisk

Evening Networking Drinks Reception

  1. Evening Networking Drinks Reception

    Café en Seine, in the heart of Dublin, is one of the city’s most popular drinks and nightlife venues and was voted Dublin’s 2015 City Bar of the Year. The venue is laid out like one big neighbourhood with many vibrant spaces and our drinks reception will be held in The Atrium…a private area on the ground floor. Drinks and snacks will be served for apx 1.5hrs.

    It is a 10 minute coach journey from the hotel.

    For those making their own way, the address is below: 

    Café en Seine
    39-40 Dawson Street
    Dublin 2
    Ireland

Thursday 10 November

Thursday 10 November

  1. Registration and Welcome Refreshments

  2. Opening Remarks and Introduction from the Chairs

    Andrew Feilden, Chemistry Operations Director, Smithers Rapra and Carsten Worsoe, Principal Scientist Extractables and Leachables, Novo Nordisk

Toxicology

  1. Introduction to Toxicological Concepts to Evaluate Extractables and Leachables – including case studies

    Pete Watts, Director of Toxicology and Chris Waine, Toxicologist, bibra toxicology advice and consulting

    • Principles of health risk assessment – hazard characterisation, assessment factors, exposure estimation, margins of exposure
    • Role of toxicity concepts in setting E&L SCTs and AETs
    • Toxicology data – identification, quality, relevance
    • Addressing data gaps – read-across, (Q)SAR models
    • Two case studies 
  2. A Discussion of Safety Information for Extractables Associated with Pharmaceutical Polymers

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

  3. Toxicological Assessement of Extractables and Leachables within the Pharmaceutical Industry

    Wolfgang Muster | Toxicology Project Leader of Roche

  4. Networking Refreshment Break

  5. Regulatory Submissions of (Q)SAR Results for Mutagenicity Based on the ICH M7 Guideline

    Glenn Myatt | Chief Scientific Officer of Leadscope

    • The presentation will outline a computational protocol for (Q)SAR assessment of mutagenicity based on the ICH M7 guideline
    • Case studies will be used to illustrate different expert review scenarios including handling out-of-domain results
    • The presentation will also outline methods to ensure regulatory acceptable public (Q)SAR models incorporate knowledge from proprietary databases

Single-Use/Bioprocessing and BPOG

  1. BPOG Model Solvent Comparison for Extractable Testing for Single Use Systems Drug Process Manufacturing

    Jessica Shea | E&L Global Technical Services Manager of MilliporeSigma (Merck)

  2. Characterisation of E&L Compounds From Single Use Bioprocessing Solutions

    Noemi Dorival Garcia | Postdoctoral Researcher 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
    • Toe 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
  3. Networking Lunch

  4. 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 in a mAb formulation was investigated for ultrafiltration / diafiltration and protein-A affinity liquid chromatography using trace analytical methods.
    • 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.
    • Theoretical prediction of clearance factors for downstream processing steps based on ideal clearance behaviour leads to too optimistic estimation of the fate of leachables. 
  5. Peroxide- vs. Platinum-cured Silicone Tubing in Pharmaceutical Production

    Alicja Sobantka | Expert for Material Qualification of Octapharma

    • Extractable profiles of peroxide- and Platinum-cured silicone tubing used in pharmaceutical production are compared
    • The potential harm for patients from exposure to the different extractables is outlined
    • Under comparable conditions Platinum-cured silicone tubing release significantly lower amounts of largely non-toxic extractables compared to peroxide-cured silicone tubing
    • Platinum-cured silicone tubing should be preferred over peroxide-cured silicone tubing, especially in high-risk manufacturing steps where no further reduction of extractables is expected such as sterile filtration and filling
  6. Biopharmaceutical Manufacturing

    Kristina Moller | Scientist of GE Healthcare

    • Introduction to bioprocess manufacturing
    • Presentation of an extractables study
    • Discussions on analytical challenges and practical considerations of different approaches and protocols, such as BPOG
  7. Chair's Conference Summary and Closing Remarks

    Andrew Feilden, Chemistry Operations Director, Smithers Rapra and Carsten Worsoe, Principal Scientist Extractables and Leachables, Novo Nordisk

  8. Close of Conference