RESEARCHERS from the 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, have developed a new method of detecting adventitious microbial contamination in mesenchymal stromal cell (MSC) cultures, ensuring the rapid and accurate testing of cell therapy products (CTP) intended for use in patients. Utilizing machine learning to predict if a culture is clean or contaminated in a near-real time-like manner, this breakthrough method can be used during the cell manufacturing process, compared to less efficient end-point testing.
Cell therapy has, in recent years, become a vital treatment option for a variety of diseases, injuries and illnesses. By transferring healthy human cells into a patient’s body to heal or replace damaged cells, cell therapy has shown increasing promise in effectively treating cancers, autoimmune diseases, spinal cord injuries, and neurological conditions, among others. As cell therapies advance and hold the potential to save more lives, researchers continue to refine cell culture manufacturing methods and processes to ensure the safety, efficiency and sterility of these products for patient use.
The anomaly detection model developed by CAMP is a rapid, label-free process analytical technology (PAT) for detecting microbial contamination in cell cultures. The team’s research is explained in an oral abstract “Process Development and Manufacturing: Anomaly Detection for Microbial Contamination In Mesenchymal Stromal Cell Culture“, published recently in the prestigious journal Cytotherapy.
“The practical application of this discovery is vast: when combined with at-line technologies, the model can be used to continuously monitor cultures grown in bioreactors at Good Manufacturing Practice (GMP) facilities in-process. Consequently, GMP facilities can conduct sterility tests for bacteria in spent culture media more quickly with less manpower under closed-loop operations. Lastly, patients receiving cell therapy as part of their treatment can be assured that products have been thoroughly evaluated for safety and sterility,” said Shruthi Pandi Chelvam (pix), lead author and Research Engineer at SMART CAMP who worked with Derrick Yong and Stacy Springs, SMART CAMP Principal Investigators, on the development of this method.
