TOPIC 429 - A NEW PARADIGM FOR AUTOLOGOUS AND ALLOGENEIC CELL THERAPY MANUFACTURING (SBIR)

Proteios技术公司开发了一种专有平台，不依赖抗体或磁珠来分离细胞亚群。该平台已经在T细胞上使用CD4和CD8亚群进行了验证，用于生产自体CAR-T细胞疗法。他们目前正在扩展自然杀伤(NK)细胞分离的平台，用于生产自体CAR-NK细胞疗法和同种异体NK细胞疗法。该提案的第一阶段将允许Proteios构建一个工作台原型，以验证其用于生产CAR-T细胞疗法的平台的扩大规模，并用于与当前的制造方法进行基准比较。Proteios的模块化方法将提供灵活性，以适应细胞治疗的新方法，因为研究人员能够用他们的研究工具分离新的细胞亚群。Proteios的愿景是继续构建一个规模的cGMP原型，并应用他们的技术来帮助降低医疗保健疗法的成本，包括细胞疗法和基因疗法。

Proteios Technology has developed a proprietary platform that does not rely on antibodies nor magnetic beads to isolate cell subpopulations. The platform has been validated on T cells using the CD4+ and CD8+ subpopulations for the production of autologous CAR-T cell therapies. They are currently extending the platform for the isolation of Natural Killer (NK) cells for the production of autologous CAR-NK cell therapies and allogeneic NK cell therapies. Phase I of the proposal will allow Proteios to construct a bench prototype to validate the scale-up of their platform for the production of CAR-T cell therapies and for benchmarking against current manufacturing methods. Proteios’ modular approach will provide the flexibility to adapt to new approaches to cell therapies as researchers are able to isolate new cell subpopulations with their research instrument. Proteios’ vision is to move on to construct an at-scale cGMP prototype and apply their technologies to help lower the cost of healthcare therapies, including cell therapies and gene therapies.