RaSTA (Rapid Sterility Testing Approach)
Lead Participant:
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD
Abstract
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.
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.
Lead Participant | Project Cost | Grant Offer |
---|---|---|
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD | £430,346 | £ 215,173 |
  | ||
Participant |
||
GLAXOSMITHKLINE PLC | ||
CELL THERAPY CATAPULT LIMITED | £297,853 | £ 297,853 |
LGC LIMITED | £243,000 | £ 121,500 |
INNOVATE UK |
People |
ORCID iD |
Nigel Richardson (Project Manager) |