Critical Analytics for Manufacturing Personalized-Medicine (CAMP) Interdisciplinary Research Group (IRG) at Singapore-MIT Alliance for Research and Technology (SMART), MIT’s research enterprise in Singapore, in collaboration with Singapore Center for Environmental Life Sciences Engineering (SCELSE), have developed a novel method capable of identifying contaminants in T-cell cultures within 24 hours. Traditional sterility methods are laborious and can take between seven to 14 days.

The method detects low-abundance levels of microbial contaminants and determines their types, ensuring therapeutics like T-cell therapies are free of contamination, with a faster turnaround. This helps reduce the risk for patients and speeds up the process.

SMART CAMP’s method aims to enhance both the safety and efficiency of cell therapy manufacturing, for improved patient outcomes and a more streamlined production process.
 
SMART’s method uses third generation nanopore long-read sequencing methodology to identify harmful microorganisms, followed by an advanced machine learning algorithm, computational analysis, and optimization. Through this process, researchers successfully identified the presence and types of microbial contaminants even at low abundance levels while also achieving this more quickly than standard compendial tests.

SMART CAMP is preparing to initiate testing to evaluate the integration of the novel T-cell sterility test into their processes and to further enhance the accuracy of contamination detection, while future research will focus on providing a similar level of detection for viruses and is currently being finalised at MIT. 

“The practical application of this discovery is vast; it offers faster product validation for biopharmaceutical manufacturers, reducing downtime and potentially accelerating product-to-market timelines,” said James Strutt, senior post-doctoral associate at SMART CAMP and first author of the paper. “These advancements hold significant promise for the biopharmaceutical industry, as they not only enhance quality control but also improve overall efficiency and cost-effectiveness, ultimately benefiting patients by ensuring the safety and reliability of cell therapy products.”
 
“Our rapid method offers a more efficient way to not only detect microbial contamination but identify the contaminating species,” said Stacy Springs, Principal Investigator at SMART CAMP and Executive Director at MIT Center for Biomedical Innovation. “We demonstrated that this method can deliver a high-sensitivity microbial sterility assessment within just 24 hours, providing a valuable tool for researchers and hopefully practitioners in the near future.”