Qepler | summits & conferences | Extractables & Leachables Summit, 15-16 October 2019
Event Location:
Berlin, Germany
NH Collection Berlin Friedrichstrasse Friedrichstraße 96
15 October 2019 - 16 October 2019

Conference Overview

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.

The featured talks on:

  • USP <665> draft standard: A rational risk-based approach to characterization of polymeric biopharmaceutical manufacturing systems.
  • Strategies for assessment of impurities and E&Ls.
  • Safety assessment of extractables/leachables: Challenges with different administration routes.
  • Toxicological assessment of non-genotoxic E&L.
  • Challenges and pitfalls during E&L studies and how to handle them.
  • Setting up effective E & L Studies: extraction and right conditions selection, leachable study monitoring and compounds selection, leachable study design.
  • Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile Filtration.
  • Data Integrity.
  • Extractables and Leachables challenges of for prefilled syringes.
  • The rubber formulation composition and its impact on extractables and leachables.
  • Leachables strategies for finished biopharmaceuticals.
  • Adoption of standardized extractables datasets for single-use system qualification and risk assessment.

Meet our Speakers

Our Sponsors

Speaker Sponsor
Intertek (Schweiz) AG



AbbVie - AiCuris Anti-infective Cures GmbH - Angelini ACRAF s.p.a. - B. Braun - Bayer - Bayer AG - Borealis Polymere GmbH - Brooks Life Sciences - Claudia Heldt - Daicel Chiral Technologies (India) Pvt Ltd - Datwyler Pharma Packaging International NV - Datwyler Sealing Solutions - EirGen Pharma - Engelhard Arzneimittel GmbH & Co KG - F. Hoffmann-La Roche Ltd - GSK - GSK Vaccines - Hall Analytical Laboratories Limited - HTL-Strefa S.A. - Intertek (Schweiz) AG - Iterum Therapeutics - Lyomark Pharma GmbH - Maven E&L Ltd - Medichem - Merck - Merck KGaA - Nelson Labs - Novartis Institutes for BioMedical Research - Novo Nordisk - Pall Biotech - Patheon, by Thermo Fisher Scientific - PHARMIDEA SIA - Purus Plastics - RMS Foundation - Safetree Consulting e.U. - Sandoz - Sanofi - Sanquin Plasma Products - Sartorius Stedim Biotech - SAS Laboratoire Aguettant - SCHOTT AG - SE Tylose GmbH & Co. KG - SGS Institut Fresenius GmbH - Smithers Rapra Ltd. - Synthon Biopharmaceuticals BV - Vifor (International) AG - West Pharmaceutical Services GmbH & Co. KG - ZETA GmbH - Others

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