Novel AI-Powered Method Rapidly Detects Microbial Contamination in Cell Cultures
Researchers at the Singapore-MIT Alliance for Research and Technology (SMART), specifically within the Critical Analytics for Manufacturing Personalized-Medicine (CAMP) interdisciplinary research group, in collaboration with MIT, A*STAR Skin Research Labs, and the National University of Singapore, have pioneered a new method for the swift and automated detection of microbial contamination in cell therapy products (CTPs). This innovative approach leverages ultraviolet (UV) light absorbance measurements of cell culture fluids, coupled with machine learning algorithms to identify patterns indicative of microbial presence. This promises to significantly cut down the time needed for sterility testing, thereby accelerating the availability of CTP doses for patients.
Cell therapy is emerging as a groundbreaking approach to treating various diseases, including cancers, inflammatory conditions, and chronic degenerative disorders. A critical hurdle in CTP manufacturing is the need to ensure cell cultures are contamination-free before administration. Traditional sterility testing methods can take up to 14 days, potentially delaying treatment for critically ill patients. While rapid microbiological methods (RMMs) can shorten this period to seven days, they often require complex procedures and skilled personnel.
The new method developed by SMART CAMP researchers addresses these challenges by providing a faster and simpler alternative. Their research, published in Scientific Reports under the title “Machine learning aided UV absorbance spectroscopy for microbial contamination in cell therapy products,” details how UV absorbance spectroscopy, combined with machine learning, enables real-time, non-invasive detection of cell contamination in early manufacturing stages. The method eliminates the need for cell staining or invasive extraction processes and delivers results in under 30 minutes. It offers a clear “yes/no” contamination assessment, making it suitable for automation and continuous monitoring.
Shruthi Pandi Chelvam, senior research engineer at SMART CAMP and first author of the paper, emphasizes that this method is intended as a preliminary safety step in CTP manufacturing. It allows for early detection of contamination, enabling timely corrective actions and optimized resource allocation. The process would reserve the use of more resource intensive RMMs only when a potential contamination is detected.
Rajeev Ram, Principal Investigator at SMART CAMP and Clarence J. LeBel Professor at MIT, highlights the method’s potential to streamline cell therapy manufacturing by reducing manual tasks and operator variability. Automated cell culture sampling and continuous monitoring can significantly decrease the risk of contamination and accelerate the manufacturing timeline.
Future research will focus on expanding the method’s applicability to a broader range of microbial contaminants and cell types. The team also envisions applications beyond cell therapy, including microbial quality control testing in the food and beverage industry.
This innovative method represents a significant advancement in ensuring the safety and efficiency of cell therapy manufacturing, offering hope for faster and more reliable treatments for patients in need.
