On-Demand Webinar: Implementing a Real-Time PCR-Based Method For Sterility Release Testing of ATMPS
Duration: 38 minutes
Overview
Currently established rapid methods for sterility testing of advanced therapy medicinal products (ATMPs) are mostly based on growth-based processes or the detection of metabolic activities. However, the requirements for real-time measurement and the testing of cell-containing products cannot be met with most of these methods.
In contrast, the real-time polymerase chain reaction (PCR) methodology offers a sterility test on cellular products with determination of the results on the same day. The required detection limit of < 100 CFU according to USP <1071> can be met.
A particular challenge here lies in the implementation of the molecular biological method in a multi-room Grade A cleanroom environment. Practical implementation of the technique, considering the possible risk factors will be presented.
Key Takeaways
Understand how real-time PCR can be implemented as sterility testing method for ATMPs
Discover how Yasmin Heynen designed the setup and risk analysis for the implementation of the rapid sterility testing in a cleanroom class A
Learn about the validation strategy at Sartorius including the authorities’ requirements for rapid microbiological methods
Webinar Speakers
Dr. Alexandra Mueller-Scholz
Lead PCR & Microbiology Application Development Team
Sartorius
Alexandra holds a Masters degree in Biotechnology from the Technical University of Braunschweig (Germany, 2010) and a PhD in Live Science from the University of Hannover (Germany, 2014). She did her PhD in cooperation with Sartorius Stedim Biotech where she started working as scientist in the department of R&D Microbiology in February 2014.
Yasmin Heynen
Molecular Development
Labor LS
In 2018, Yasmin started her training as biological laboratory technician at Labor LS. Simultaneously, she began her studies at the University of Trier that she finished with a Bachelor of Science in Biological and Pharmaceutical Engineering. She is part of the department for Molecular Development at Labor LS as a Specialist Manager for the development and validation of molecular biological methods.