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.

Learning Objectives:

1. Review how real-time PCR can be implemented as sterility testing method for ATMPs

2. Discover how the setup and risk analysis were designed for the implementation of the rapid sterility testing in a cleanroom class A

3. Identify the validation strategy, including the authorities’ requirements for rapid microbiological methods