Celling therapy is a promising new border in medicine, especially in the treatment of diseases such as cancer, inflammatory diseases and chronic degenerative disorders by manipulating or replacing cells to restore function or fight. However, the main challenge in the production of CTP is quickly and effectively ensures that the cells are free from pollution before serving patients.
Existing methods of testing sterility, based on microbiological methods, are labor intensive and require up to 14 days to detect pollution, which may negatively affect critically ill patients who need immediate treatment. Although advanced techniques, such as fast microbiological methods (RMM), can reduce the testing period to seven days, they still require complex processes, such as cell extraction and growth enrichment media, and they are highly dependent on qualified employees to procedures, such as sample extraction, measurement and analysis. This creates an urgent need for new methods that offer faster results without prejudice to CTP quality, meeting the patient's use schedule and the use of a simple work flow, which does not require additional preparation.
This method offers significant advantages in relation to traditional sterility tests and RMM, because it eliminates the need for cell coloring to identify marked organisms, avoids the invasive process of cell extraction and provides results below half an hour. Provides an intuitive, quick assessment of “YES/NO” pollution, facilitating the automation of sampling of cell culture with a simple work flow. In addition, the developed method does not require specialized equipment, which causes lower costs.
“This rapid, label-free method is designed to be a preliminaries steppe in the ctp manufacturing process as a forms of continuous safety testing, which allows users to detect contamination early and implementation Timemly Corrective Actions, Including the Use of Use of Use of Rmms Only Only Ony when? Possible Contamination is detected.
“Traditionally, the production of cellular therapy is labor -intensive and is subject to the volatility of the operator. By introducing automation and machine learning, we hope to improve the production of cell therapy and reduce the risk of pollution. In particular, our method supports the taken of the taken of cell breeding samples in designated compartments in order to check contamination, which reduces manual tasks, such as samples, such as samples, and measurements, and measurements, and measurements, and measurements, and measurements, and measurements Analysis. This includes continuous and permanent cells and contain content containing and contain content and containing control.
Going further, future research focuses on expanding the use of the method to cover a wider range of pollution of microorganisms, in particular representative of good production practices for current environments and previously identified CTP pollution. In addition, the model's resistance can be tested to more types of cells except MSC. In addition to the production of cell therapy, this method can also be used for the food industry and drinks as part of testing the quality of microorganisms to ensure safety standards food products.