Programme
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
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
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Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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