Conference: Cells, Tissues and ATMPs and Alternative Microbiological Methods

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

Regulatory Expectations for Rapid Sterility Testing of ATMPs
Dr Michael Miller, Microbiology Consultants

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
Marina Jorge Miranda, Tentamus

Short Shelf Life and Sterility Testing - Challenges of Cell-Based ATMP Market Supply
Mareike Klingler, 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.

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 Laboratory Technician.

Marina Jorge Miranda, Tentamus Pharma & Med, Germany. Deputy Head of Cell- and Immune Analytics.

Mareike Klingler, Tetec, Germany. Technician Quality Control Microbiology / Sterility testing.

Mahsa Mohammadi, Novartis, Switzerland. Senior AS&T Specialist/ Analytics, Launch and Transfer-Larg Molecules.