Live Online Conference: Challenges in Bioanalytical and Analytical Laboratories - Day 1 - from Bioassays to ATMP Analytics

Objectives

This Live Online 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 Live Online Conference 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

09.00 - 09.30 h
Introduction and Organisationals

09.30 - 10.15 h
Key Note: Current European Pharmacopoeia Developments, with a Focus on Microbiology
Dr Emmanuelle Charton, EDQM, Head of Divison B

10.15 – 10.45 h Break

10.45 – 11.15 h - A journey beyond Automation in High-Content Analysis for LIve-cell Imaging Research and Drug Discovery
Gerd Heimlich, Yokogawa

11.15 – 11.45 h - A complex Cell-based Bioassay for efficient LIfecycle Management of Analytical Procedures
Melanie Wallisch, Rentschler

11.45 – 12.15 h - Development of a Cell-based Binding Assay according to QbD
Sabrina Rottal, VelaLabs

12.15 – 12.45 h - Questions and Answers

12.45 – 13.45 h Break

13.45 – 14.15 h - Mass Spectrometric Evaluation of Host Cell Protein Patterns in Downstream Process and Biopharmaceutical Products
Dr Daniel M. Waldera-Lupa, Protagen Protein Services

14.15 – 14.45 h - Simultaneous Bioanalytical Monitoring of Cytotoxicity and Biomarker Release via Higher Throughput Assays
Jacob G. Tesdorpf, Perkin Elmer

14.45 – 15.15 h - Validation of Bioanalytical Testing for a Therapeutic mAb using MesoScaleDiscovery
Max Roucka, VelaLabs

15.15 – 15.30 h Break

15.30 – 16.00 h - New Approaches for Analyzing ATMPs in GMP Environment
Dr Markus Fido, MFI Bio Consulting

16.00 – 16.30 h - Advanced Analytical Approaches for Accelerated Development of Gene Therapy Products
Dr Nicolas Brauckhoff, Protagen Protein Services 

16.30 – 17.00 h - Question and Answers