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Bioanalytics and Bioassays - Challenges for Biological Drug Substances and Products

12 November 2019

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 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

Description of analytical procedure and validation, a regulator's view
Luka Kosec, JAZMP - Slovenian medicinal Agency

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 bioassays
Klemens Weitenthaler, VelaLabs – A Tentamus Company

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

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

Speakers

Thomas Fechner, Agilent Technologies
Principal Scientist.

Luka Kosec, JAZMP - Slovenian medicinal Agency
Quality Assessor.

Patrick Jackson, GSK
Investigator in CMC-Analytical.

Dr Ruth Röder, Microcoat Biotechnologie
Project Manager Endotoxin Services.

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

Prof. Dr. Dr. Hartwig Schulz, Consulting and Project Management for Medicinal and Aroma Plants
Formerly he used to work for the Julius Kühn Institute.

Klemens Weitenthaler, VelaLabs – A Tentamus Company
Technical Expert.