SMART Researchers Develop Rapid Contamination-Detection Method for Safer T-Cell Therapy
Dr James Strutt, Senior Postdoctoral Associate at SMART CAMP
Traditional sterility tests for bacteria and fungi in T-cell cultures take up to 14 days, whereas a new method developed by researchers at SMART in Singapore can detect contaminants within 24 hours. Using advanced nanopore sequencing and machine learning, this breakthrough expedites the identification of microbes in T-cell cultures, revolutionizing safety measures in biopharmaceutical manufacturing.
Led by the Critical Analytics for Manufacturing Personalized-Medicine (CAMP) Interdisciplinary Research Group at SMART, in collaboration with SCELSE and MIT, this novel method swiftly identifies low-abundance microbial contaminants in T-cell therapies, ensuring product safety and reducing risks for patients.
Cell therapies, like CAR-T treatments for blood-related cancers, rely on uncontaminated products for patient safety. The current seven-to-14-day sterility tests are laborious, making faster methods crucial, especially for patients in urgent need of treatment. SMART’s breakthrough promises enhanced safety and efficiency in cell therapy manufacturing, improving patient outcomes and streamlining production.
Published in Microbiology Spectrum, the research details a machine learning-based detection method using long-read sequencing to differentiate clean from contaminated samples swiftly and accurately. This cutting-edge approach combines nanopore sequencing and machine learning algorithms to identify contaminants at low levels.
Dr. James Strutt, Senior Postdoctoral Associate at SMART, emphasizes the broad application of this discovery in biopharmaceutical manufacturing. The method’s efficiency promises faster product validation, reducing downtime and potentially accelerating market timelines, benefiting patients through enhanced safety and reliability.
Presented at various scientific conferences, the research is moving towards integrating the novel sterility test into manufacturing processes. Future studies aim to extend this approach to virus detection, aligning with SMART’s goal of swift and accurate contamination identification.
Dr. Stacy L. Springs, Principal Investigator at SMART CAMP and Executive Director at MIT Center for Biomedical Innovation, highlights the method’s efficiency in identifying contaminating species within 24 hours, offering a valuable tool for researchers and potentially practitioners.
Supported by the National Research Foundation Singapore, this research aligns with SMART’s commitment to advancing reliable contamination detection methods for safer biopharmaceuticals.
Category: Technology & Devices
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