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Conference: Cells, Tissues and ATMP and Alternative Microbiological Methods
23 November 2022
09.15 - 10.00 h
Congress Keynote: Impurities - USP Draft Chapter <477> User-Determined Reporting Thresholds (UDRT), and Other Relevant Chapters
Dr Christian Zeine, Senior Manager Scientific Affairs EMEA
Microbiological Control of ATMP
Chiemezie Nwakire, Neuroplast
Implementation of a Comprehensive Rapid Microbial Contamination Control Platform for Testing of Sterile Pharmaceuticals and Cell-Based Therapies using ATP Bioluminescence
Stefan Gärtner, Labor LS
Lucia Ceresa, CRL
Ultra-Rapid Microbial Detection in Cell & Gene Therapy Products: the closest you can be to Real-Time Release
Corinne de la Foata, bioMerieux
Viral Safety – Evaluation of Eukaryotic Cell Bank Purity with a Special Focus on Adventitious Agents and Replication Competent Viruses
Larissa Nkenmei-Pietsch, Tentamus
Short Shelf Life and Sterility Testing - Challenges of Cell Based ATMP Market Supply
Debora D`Amico, Tetec
Rapid Sterility by qPCR for ATMPs
Dr Anja Fritsch, Confarma
ScanRDI System - Validation and Implementation of an Alternative Sterility Test (Solid Phase Cytometry) for a Cell and Gene Therapy Product
Mahsa Mohammadi, Novartis
Implementation of a Real Time PCR-based Method for Release Testing the Sterility of ATMPs, a Practical Approach
Yasmin Heynen, Labor LS
Dr Michael Miller, Microbiology Consultants
Dr. Lucia Ceresa, Charles River Laboratories, Italy. Senior Technology and Market Development Manager.
Debora D`Amico, Tetec, Germany. Team Leader Quality Control Microbiology & Hygiene Monitoring.
Dr Anja Fritsch, Confarma, France. Chief Scientific Officer.
Corinne de la Foata, bioMerieux, France. R&D Senior Manager.
Stefan Gärtner, Labor LS, Germany. Head of Department - Sterile Products Rapid and Alternative Methods.
Yasmin Heynen, Labor LS, Germany. Biological Laboratoty Technician.
Mahsa Mohammadi, Novartis, Switzerland. Senior AS&T Specialist/ Analytics, Launch and Transfer-Larg Molecules.
Chiemezie Nwakire, Neuroplast BV, The Netherlands. QA Manager/Trainee QP.
Larissa Nkenmei-Pietsch, Tentamus, Germany. Head of Cell and Immune Analytics.