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UK funding (£634,526): RaSTA (Rapid Sterility Testing Approach) Ukri1 Aug 2016 UK Research and Innovation, United Kingdom
Overview
Text
RaSTA (Rapid Sterility Testing Approach)
| 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. |
| Category | Collaborative R&D |
| Reference | 102608 |
| Status | Closed |
| Funded period start | 01/08/2016 |
| Funded period end | 31/01/2019 |
| Funded value | £634,526.00 |
| Source | https://gtr.ukri.org/projects?ref=102608 |
Participating Organisations
| GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED |
£215,173.00 |
| LGC LIMITED |
£121,500.00 |
| CELL THERAPY CATAPULT LIMITED |
£297,853.00 |
The filing refers to a past date, and does not necessarily reflect the current state. The current state is available on the following page: Glaxosmithkline Research & Development Ltd., London.
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