Design Of CAR-T Cell Automated Preparation System And Its Software And Hardware Development

The importance of therapeutic effect and application potential of CAR-T immunotherapy have been recognized by the medical community.However,there are still many obstacles on the road to the popularization of clinical application.Conventional artificial CAR-T cell preparation schemes are complicated,costly,inefficient and prone to cross-infection,and it can not meet the industrialization requirements of CAR-T immunotherapy clinical grade preparation,Therefore,the development of large-scale,automated,high-quality but low-cost CAR-T cell production and preparation systems has become one of the key issues to be addressed in CAR-T immunotherapy.Based on this,we have designed and developed an instrument system that can be used for the automated preparation of CAR-T cells.The system integrates all the steps of conventional preparation of CAR-T cells,T-cell sorting,activation,genetic modification,and the culture and expansion of CAR-T cells can be performed simultaneously on a single instrument.In this system,T-cell sorting and activation are performed by micro-magnetic beads,T-cell genetic modification is carried out by lentivirus infection,and the use of specially designed closed-loop pipe consumables combined with electromagnetic valves and peristaltic pumps enable the transfer of relevant samples and formulations in different functional areas to effectively avoid potential exogenous contamination.The system uses the STM32 microprocessor as the control core and has written software control programs based on uC/OS-? and STemWin,which can control and schedule each preparation link.After completing the system design and the development of software and hardware,all functional modules of the system are tested.The results show that the system has excellent environmental control performance,its temperature control accuracy is less than 0.1 degrees Celsius,and the carbon dioxide concentration can be continuously stabilized between 4.8% and 5.3%,which can meet the needs of cell culture;CAR-T automated preparation steps in the system can also be successfully executed in accordance with the software instructions.