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Analytical Challenges for Biological Drug Substances and Products

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

The Revised FDA Guidance on the validation of analytical methods
Dr Markus Fido, VelaLabs

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

  • Development of Potency assays
  • What is needed for the different phases
  • Setting SST parameters for Potency assays
  • Challenges with specificity

Challenges in Bioactivity Determination
Dr Ulrike Herbrand, CRL

  • bioassays for immune checkpoint mAbs
  • bioassays for mAbs with viral targets
  • bioassays for characterization and lot release of antibody drug conjugates (ADCs)

The interdependence of Bioassays and Structural characterisation
Klemens Weitenthaler, VelaLabs

  • Potency evaluation using a bioassay: Mode of Action and evaluation models
  • Limitations of information gained
  • Orthogonal structural characterisation
  • How certain modifications impact the Bioassay performance:
    • Deamidations
    • Oxidations
    • Glycovariants
    • Amino Acid Substitutions
  • Benefits of interdisciplinary teams in the Biosimilar field (case study)

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

  • Background single Molecular detection technology
  • Implementation of SIMOA at a contract lab
  • Application of SIMOA for ultrasensitive detection of large molecules
  • Transfer of a classical ELISA for improvement of sensitivity and comparison to other platforms

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

  • Host Cell DNA
  • Automation
  • Performance Qualification

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

  • setting up and managing a software validation project
  • setting up URS
  • programming and testing
  • routine use
  • benefit over paper based process

Speakers

Dr Jan Amstrup, Novo Nordisk, Denmark
Principal Scientist.

Dr Markus Fido, VelaLabs, Austria
CEO and Founder of VelaLabs. Responsible for Finance & Controlling, Regulatory Affairs & Quality Operations.

Dr Michael Haberl, Microcoat Biotechnologie, Germany
Director Quality Assurance.

Dr Alice Hellwig, Microcoat Biotechnologie, Germany
Director Laboratory Services.

Dr Ulrike Herbrand, Charles River Laboratories, Germany
Scientific Supervisor Bioassay R&D.

Kyrillos Kyriosoglou, Roche Diagnostics, Germany
Chemical Engineer.

Klemens Weitenthaler, VelaLabs, Austria
Technical Expert.