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Bioanalytics and Bioassays - Challenges for Biological Drug Substances and Products

12 November 2019


This Conference will inform you about GMP, GLP and GCLP principles and how they apply to potency Bioassay, limits tests, pharmacokinetics.

You become informed about

  • International regulatory requirements
  • Current developments of methodology
  • Pharmacokinetics
  • Biosimilar characterization


The number of biopharmaceutical products is increasing in the clinic and in the market. Their excellent targeting ability is the result of a high complexity. Therefore suitable analytical tests are necessary to ensure the structure and purity of biopharmaceutical drug substances and drug products. But the complexity cannot be measured by analytical tests alone. Therefore, the development process of all biopharmaceutical products requires non-analytical tests to fully evaluate their functionality and safety. Biopharmaceutical development is a multi-disciplinary effort that involves many professionals with diverse backgrounds. This course will help team members without the appropriate technical background by clarifying the timelines, requirements and significance of Bioassays based testing. The types of methods that will be addressed are cell-based assays, immunoassays and molecular assays.

Target Audience

  • Manufacturing process professionals
  • QA/QC staff and regulatory personnel
  • Clinical staff, pharmacologists and toxicologists
  • Project Managers & outsourcing personnel
  • Analytical chemists and biochemists


Congress Keynote 12.11.2019: New ICH Q14 and ICH Q2 Revision – an industry view (Key Note Presentation at the Plenum)

New ICH Q14 and ICH Q2 Revision – an industry view (Key Note Presentation at the Plenum)
Dr Joachim Ermer, Sanofi-Aventis Deutschland
Head of QC Lifecycle Management Frankfurt Chemistry

Regulatory Requirements of analytical procedure and validation
Dr Norbert Handler, RD&C Research, Development & Consulting 

How to overcome some of the challenges when analysing Biological Drug Substances and Products
Thomas Fechner, Agilent

Analytical Quality by Design Through the Lifecycle
Patrick Jackson, GSK

State-of-the-Art evaluation of potency & cell-based bioassays
Thomas Ludwig, VelaLabs – A Tentamus Company

Process for automatization of a Bioassay
Dr Marcus Gutmann, Microcoat Biotechnologie

Application of fast and non-destructive analysis techniques in quality and in-process control
Prof. Dr. Hartwig Schulz, formerly Julius Kühn-Institut (JKI)

Lectin Array – a novel technology for investigation of pharmaceutical products
Markus Roucka, VelaLabs – A Tentamus Company


Dr Markus Fido, VelaLabs – A Tentamus Company


Thomas Fechner, Agilent Technologies, Germany
Principal Scientist.

Dr Marcus Gutmann, Microcoat Biotechnologie, Germany
Project Leader Endotoxin Services.

Dr Norbert Handler, RD&C Research, Development & Consulting, Germany
Managing Director.

Patrick Jackson, GSK, UK
Investigator in CMC-Analytical.

Thomas Ludwig, VelaLabs – A Tentamus Company, Austria
Group Leader for cell-based assays.

Markus Roucka, VelaLabs – A Tentamus Company, Austria
Lab Head and Business Development.

Prof. Dr. Hartwig Schulz, Consulting and Project Management for Medicinal and Aroma Plants, Germany
Prof. Dr. Hartwig Schulz used to work for the Julius Kühn-Institut (JKI).