The new method successfully performs sterility assessments within 24 hours
Researchers from the Singapore-MIT Alliance for Research and Technology’s (SMART) Critical Analytics for Manufacturing Personalized-Medicine (CAMP) Interdisciplinary Research Group have collaborated to develop safer T-cell therapies.
In partnership with the Singapore Centre for Environmental Life Sciences Engineering and the Massachusetts Institute of Technology (MIT), researchers have developed a novel method to identify contaminants in T-cell cultures within 24 hours.
Cell therapies are significant when treating incurable diseases because they work to place new, healthy cells into the body to replace diseased or damaged ones.
Currently, sterility methods take between seven and 14 days to ensure that medical treatments are free from harmful contaminants, improve the safety and efficacy of cell therapy manufacturing and reduce the risk of treatments for patients.
SMART CAMP’s method aims to enhance both the safety and efficacy of cell therapy manufacturing much faster to improve patient outcomes and streamline production processes.
Published in the Microbiology Spectrum and supported by the National Research Foundation (NRF), the new method detects contaminants in T-cell structures within a day using cutting-edge technology, including third-generation nanopore long-read sequencing and DNA extractions.
Utilising an advanced machine learning algorithm, computational analysis and optimisation, researchers aim to use the method to differentiate between clean and contaminated samples and pinpoint organisms most likely to cause contamination.
SMART CAMP is preparing to initiate testing to evaluate the integration of the novel T-cell sterility test into their processes and further enhance the accuracy of contamination detection.
Additionally, MIT researchers will focus on providing a similar level of detection for viruses to provide more robust and dependable sterility assessments.
Dr James Strutt, senior postdoctoral associate at SMART CAMP, said: “These advancements hold significant promise for the biopharmaceutical industry, as they… enhance quality control… [and] improve overall efficiency and cost-effectiveness, ultimately benefitting patients by ensuring the safety and reliability of cell therapy products.”
