UK-Förderung (634.526 £): RaSTA (Rapid Sterility Testing Approach) Ukri 01.08.2016 Forschung und Innovation im Vereinigten Königreich, Großbritannien

RaSTA (Rapid Sterility Testing Approach)

Zusammenfassung	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.
Kategorie	Collaborative R&D
Referenz	102608
Status	Closed
Laufzeit von	01.08.2016
Laufzeit bis	31.01.2019
Fördersumme	634.526,00 £
Quelle	https://gtr.ukri.org/projects?ref=102608

GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED	215.173,00 £
CELL THERAPY CATAPULT LIMITED	297.853,00 £
LGC LIMITED	121.500,00 £

Die Bekanntmachung bezieht sich auf einen vergangenen Zeitpunkt, und spiegelt nicht notwendigerweise den heutigen Stand wider. Der letzte verfügbare Stand wird auf folgender Seite wiedergegeben: Glaxosmithkline Research & Development Ltd., London, Großbritannien.