RaSTA (Rapid Sterility Testing Approach)

Current safety methods for product release such as the compendial sterility test are inadequate for a large

number of autologous cell and gene therapy products due to their short shelf life. This problem is exacerbated

by the long complex manufacturing processes during which microbial contamination can occur. As a result

sterility testing has to be performed during manufacture and the products released with an element of risk.

This project, led by GSK and supported by the Cell Therapy Catapult and LGC, will address this issue by

developing a rapid sterility test (<1hr) based on a novel technology to allow real time product release. The

project will also develop a high sensitivity approaches which will quantify live and dead microbial contaminants

for in-process testing and be used to validate the readout of the rapid sterility test. These technologies will be a

major innovation for the field and will provide a much needed technical solution to allow cell and gene

therapies to be tested for safety prior to their use.