IGF::OT::IGF Microbioreactors for Manufacturing Autologous Cell-Based Cancer Immunotherapies

基于自体细胞的癌症免疫疗法等个性化医疗产品的制造是一个巨大的挑战。当生产批量为单一专利时，需要新的制造系统来降低成本并提高这些个性化产品的质量。该项目的长期目标是开发一个基于微生物反应器的制造平台，以实现每年超过10万次个体治疗的自体细胞疗法的低成本制造。初步可行性将通过在现有微生物反应器中培养t细胞和优化工艺条件以获得最大细胞密度来评估。此外，将进行工艺开发，以提高基因修饰靶细胞的效率，以提高产品质量和工艺稳健性。最后，设计了一种专门用于自体细胞治疗制造的微生物反应器系统，并进行了质量控制样品制备。

The manufacture of personalized medicine products such as autologous cell-based cancer immunotherapies is a tremendous challenge. When the manufactured batch size is for a single patent, new manufacturing systems are needed to reduce the cost and improve the quality of these individualized products. The long-term objectives of this project are to develop a microbioreactor-based manufacturing platform to enable the low cost manufacture of autologous cell therapies at scales exceeding 100,000 individual therapies per year. Initial feasibility will be assessed by cultivating T-cells in existing microbioreactors and optimizing process conditions for maximum cell density. In addition, process development to improve the efficiency of genetically modifying the target cells will be performed in order to improve product quality and process robustness. Finally a microbioreactor system specifically for autologous cell therapy manufacturing with quality control sample preparation will be designed.