Cells, Tissues and ATMP and Alternative Microbiological Methods (Day 2) This conference is part of PharmaLab Congress 2022

Programme

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