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Analytical Challenges for Biological Drug Substances and Products Objectives

21 November 2018

Objectives

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

Background

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 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

Programme

What do we need of information from a potency assay?
Dr Jan Amstrup, Novo Nordisk

Challenges in Bioactivity Determination
Dr. Ulrike Herbrand, CRL

The interdependence of Bioassays and Structural characterisation
Clemens/Vicky, VelaLabs

LER – An alternative Explanation
John Dubczak, CRL

Single Molecular Detection – A new technology
Dr Alice Hellwig, Microcoat

Getting Host Cell DNA analysis up to speed with an automated System
Kyrillos Kyriosoglou, Roche

Development and Validation of an Excel workbook for automated sample information management in the analytical lab
Dr Michael Haberl, Microcoat