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Conference: Cells, Tissues and ATMP and Alternative Microbiological Methods

23 November 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

Moderation

Dr Michael Miller, Microbiology Consultants

Speakers

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.

Day 1 on 22 November 2022

Below please find Day 1 of the respective conferences, each of which will take place on 22 November:

>> Quality Control of Cells, Tissues and ATMPs

>> Alternative and Rapid Microbiological Methods