Cell therapy represents a new promising border in medicine, especially in the treatment of diseases such as cancers, inflammatory diseases and chronic degenerative disorders by handling or replacing cells to restore function or fight against disease. However, a major challenge in CTP manufacturing is to secure quickly and effectively that cells are free from contamination before being administered to patients.
The existing sterility test methods, based on microbiological methods, are at high workforce and require up to 14 days to detect contamination, which could affect seriously ill patients who need immediate treatment. Although advanced techniques such as rapid microbiological methods (RMM) can reduce the test period to seven days, they always require complex processes such as cell extraction and growth of growth, and they strongly depend on skilled workers for procedures such as sampling, measurement and analysis. This creates an urgent need for new methods which offer faster results without compromising the quality of CTPs, meet the chronology of patient use and use a simple workflow that does not require additional preparation.
This method offers significant advantages compared to traditional sterility tests and RMMs, because it eliminates the need for cell coloring to identify marked organisms, avoids the invasive cell extraction process and gives results in less than half an hour. It provides an intuitive and rapid “yes / no” contamination assessment, facilitating the automation of cell culture sampling with a simple workflow. In addition, the developed method does not require specialized equipment, resulting in a lower costs.
“This quick -free method is designed to be a preliminary step in the CTP manufacturing process as a continuous safety test form, which allows users to detect contamination early and implement corrective actions in a timely time, including the use of RMMS only when possible. first author of the newspaper.
“Traditionally, the manufacture of cell therapy is with a high intensity of labor and subject to the variability of the operator. Be detected in the early stages, ”explains Rajeev Ram, Professor of Clarence J. Lebel in Electrical and IT engineering at MIT, principal researcher at Smart Camp, and corresponding author of the newspaper.
In the future, future research will focus on expanding the application of the method to encompass a wider range of microbial contaminants, in particular those representative of current practices of manufacturing practices and previously identified CTP contaminants. In addition, the robustness of the model can be tested on more types of cells outside the MSC. Beyond the manufacture of cell therapy, this method can also be applied to the food and drinks industry as part of microbial quality control tests to ensure that food products meet safety standards.
