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Live Online Conference: Challenges in Bioanalytical and Analytical Laboratories - Day 1 - from Bioassays to ATMP Analytics
10 November 2020
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
- 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 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.
- 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
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
Axel H. Schroeder, CONCEPT HEIDELBERG GmbH
Dr Nicolas Brauckhoff, Protagen Protein Services, Germany
Head of Biotherapeutical Analytics.
Dr Markus Fido, MFI Bio Consulting, Austria
Founder and CEO.
Gerd Heimlich, Yokogawa Deutschland, Germany
Senior Executive Sales - Life Innovation Business Europe.
Sabrina Rottal, VelaLabs – A Tentamus Company, Austria
Application Specialist - R&D and Analytical Development.
Markus Roucka,VelaLabs – A Tentamus Company, Austria
Jacob G. Tesdorpf,, PerkinElmer Life Sciences & Technology, Germany
Senior Director Life Science Markets.
Melanie Wallisch, Rentschler Biopharma, Germany
Quality Control Manager.
Dr Daniel M. Waldera-Lupa, Protagen Protein Services, Germany
Application Specialist Mass Spectrometry.