Extractables & Leachables for Pharma Summit 2021 - uventia

Extractables & Leachables for Pharma Summit 2021

Extractables & Leachables Summit
Event Details


Extractables and leachables (E&L) studies has now become a key component of product launch. Regulatory agencies are very concerned about the interaction between the final drug product and container closure systems, drug delivery devices, as well manufacturing components. Hence, the migration of mobile chemicals from components and ingredients used in drug production and storage demands careful evaluation.

Our dedicated online meeting brings together managers, scientists and toxicologists in the E&L field to share the latest in analytical methods for E&L, regulatory updates and compliance, risk based E&L programs, chemical characterization, toxicological risk assessment, E&L studies validation, E&L assessment in biomanufacturing and processing equipment, E&L data for selection and qualification of single use systems, material selection/screening/qualification, custom approaches for the specific type of product.

Be present at our virtual meeting to equip yourself with new tools and vital knowledge to analyse and test for extractables and leachables in biopharmaceutical development to effectively minimize E&L associated risks and assure patients’ safety and product quality.


  • E&L programs to balance costs and turnaround time.
  • Effective E&L study designs.
  • Toxicological assessment for E&L.
  • From knowns and known unknowns: managing uncertainties in the risk assessment of leachables & extractables.
  • From extractables to leachables – how to deal with complicated formulations.
  • Analytical challenges in E&L assessment.
  • How to write a toxicological risk assessment to support extractables and/or leachables profiles: a step-by-step process.
  • How to create and deploy an extractables/leachables testing program for a multi-modal company/facility.
  • Chemical characterization in biocompatibility testing of medical devices.
  • Extractables and leachables in biologics – lessons learned and hands-on solutions.
  • Predictive modeling in support of chemical safety risk assessments.
  • Extractables and leachables analysis using a quadrupole time-of-flight (QTOF) mass spectrometer and swath acquisition.
  • Single-use bioreactor material characterisation as critical issue for cho cells performance: new approaches.


CxO, VP, Directors, Heads, Managers of

  • Extractables and Leachables/ E&L
  • Analytical Chemistry/ Analytical Development/ Analytical Science
  • Product Characterisation/ Risk Assessment
  • Drug Development/ Drug Substance
  • Drug Safety/ Compound Safety/ Toxicology
  • Device Development/ Device Engineering/ Container Development
  • Good Laboratory Practice (GLP)/ Good Manufacturing Practice (GMP)
  • Manufacturing Science & Technology/ Single Use Systems
  • Bioprocessing/ Bioproduction
  • Regulatory Affairs & Compliance
  • Materials Science/ Materials Selection/ Biocompatibility
  • Packaging & Labelling
  • LC-MS/ Mass Spectrometry

[Agenda] Extractables & Leachables for Pharma Summit 2021

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.

Speaking Companies

● AbbVie, Inc. ● Albhades Provence ● Altran ● AryoGen Pharmed ● AstraZeneca ● B. Braun Medical AG ● Bayer AG ● Bio-Technology General (Israel) Ltd. / Ferring Pharmaceuticals ● Biogen ● Boehringer Ingelheim ● Butterworth Laboratories Ltd ● Carso ● Cenexi ● Chemo SA ● Chiesi Farmaceutici spa ● CMIC Pharma Science Co.,Ltd. ● Constantia Patz Ges.m.b.H. ● ConvaTec ● CSL Behring AG ● ELPEN Pharmaceutical Co. Inc. ● GSK ● GSK Vaccines ● Hall Analytical ● Illumina ● Imperial Brands ● Incyte ● Intertek (Schweiz) AG ● Intervenance NG ● Jagiellońskie Centrum Innowacji ● Laboratorio Reig Jofre, S.A. ● Lonza ● Lonza DPS ● Medtronic LTD. ● Merck Healthcare KGaA ● Merck Serono ● Microvention Inc. ● Minapharm Pharmaceuticals ● National Institute for Bioprocessing Research and Training (NIBRT) ● Nelson Labs Europe ● NNE ● Norner AS ● Novartis ● Octapharma ● Pharma Quality Europe srl ● PHARMA-DATA S.A. ● Polpharma ● ProPharma Group ● Regeneron ● S&C BEST Srl ● SaniSure ● SCIEX ● SGD Pharma ● Solvias AG ● Swissmedic ● Synthon Hispania ● Takeda ● Takeda Pharmaceuticals ● Taro Pharmaceuticals inc. ● Teva Pharmaceuticals ● UAB Teva Baltics ● UCB Biopharma SRL ● Viatris ● Waters Corporation ● Watson-Marlow Fluid Technology Group ● WuXi Biologics ● Xellia Pharmaceuticals

Speaker Board
Jack Steed
Technical Specialist
Tino Otte
Head of Sales and Consulting
Intertek (Schweiz) AG
Bill Scott
Scientist II, Materials Science
Greg Erexson
Senior Principal Research Toxicologist
Greg Erexson Toxicology Consulting, LLC
Lukas Mogler
Principal Scientist / Sr. Group Lead
Lonza DPS
Thomas Broschard
Director, Chemical Toxicology
Merck Healthcare KGaA
Alicja Sobańtka
Team Lead Corporate Material Qualification
Clemens Guenther
Director, Senior Expert Nonclinical Safety
Bayer AG
Thomas Egert
Research Scientist Pharmaceutical Contact Materials
Boehringer Ingelheim Pharma GmbH
Wenjing Zhao
Medtronic LTD.
Andrew Feilden
European E&L Strategic Director
Bicycle Therapeutics
Noemí Dorival-García
Research Fellow
NIBRT (National Institute for Bioprocessing Research and Training)
Atish Sen
Staff Scientist

Summit Agenda

◆  EL studies for single use systems used for biologics.

◆  EL studies for biologics manufacturing processes.

◆  Risk-based EL assessments.

Lonza DPS, CH

◆  Key factors in designing extraction studies.

◆  Factors to consider when designing and implementing leachable studies.

Bicycle Therapeutics, UK

◆  Assessing toxicological risk and toxicity data.

◆  PQRI recommendations on analytical and safety thresholds.

◆  Qualification thresholds and use of QSAR.

◆  Considerations on quality and safety.

Bayer AG, DE

Extractables and Leachables are a serious problem, which is getting worse with increasing complexity of packaging systems and drug matrices. In this presentation I will discuss the following topics in detail:

◆  Best study design which covers the whole product cycle from production-process to the final container closure system.

◆  Practical solutions for E&L-evaluations of complex material combinations.

◆  Potential difficulties with formulation interference during Leachables Studies including possible solutions.

◆  Unknown Extractables and Leachables and how to deal with them.

Intertek (Schweiz) AG, CH

◆  Test standards for E&L analytical assessments.

◆  Materials information – CCS and manufacturing.

◆  Choosing the right analytical methods.

◆  Data interpretaion – ID and structure, quantitation, relative response factors.

◆  Managing life cycle.

AstraZeneca, USA

◆  Conversion of ppm (mcg/L or mcg/g) to maximum daily exposure (MDE) values.

◆  Selection of the point of departure for permitted daily exposure (PDE) values.

◆  Undesirable compounds (heavy metals, mutagens, carcinogens, unknowns) identified in analytical E&L profiles.

Greg Erexson Toxicology Consulting, LLC | AbbVie Retiree, USA

◆  Know your processes; understand the full range of conditions from all modalities (monoclonal antibodies, Small molecule, gene therapy, etc.) that SUT can be exposed to.

◆  Can you apply a standard risk assessment across all modalities?

◆  Emerging guidance on new modalities like gene therapy.

Biogen, USA

◆  The importance of chemical characterization for medecal device.

◆  The general considerations of chemical characterization.

◆  Toxicological risk assessment of medical device based on chemical characterization results (tentative).

Medtronic LTD., CN

◆  Understanding Physicochemical Factors as Impacting Material Suitability.

◆  Role of Mass Transport Modeling in a Modernized Safety Risk Assessment Concept – ICH Q3E.

Boehringer Ingelheim, DE

◆  The utilization of the SCIEX X500 QTOF system to provide qualitative and quantitative E&L data.

◆  SWATH acquisition to ensure that all compounds can be both detected, identified and quantified in complex E&L matrices.

◆  SCIEX OS software provides an easy to use and accessible platform for processing, whether utilizing libraries or looking to identify and quantify true unknown compounds.


◆  Single-use technologies, in particular disposable bioreactor bags (SUBs) have become integral within the biopharmaceutical community. However, safety concerns arose upon the identification of toxic leachable compounds derived from the plastic materials.

◆  Material characterisation becomes critical to determine if substances potentially detrimental to cells are present in the films.

◆  This study includes a comprehensive evaluation of the material composition, which is supported and correlated with different types of biological tests, which demonstrates that current awareness on leachables effects has produced an improvement in the materials composition used in modern generations of SUBs for safe application in the bioprocess.


Event Details