SBIR PHASE II, TOPIC 429: A NEW PARADIGM FOR AUTOLOGOUS AND ALLOGENEIC CELL THERAPY MANUFACTURING

自体细胞疗法为癌症治疗提供了巨大的希望，但它们复杂、缓慢、劳动密集型和昂贵。医疗中心实验室通常能力有限，每月很少能治疗10名以上的患者。为了提高这些新兴的基于细胞的疗法的可用性，迫切需要能够并行处理多个患者的多种细胞疗法的先进制造方法。全自动化系统将提高这项技术的产量，预计将减少这些新兴技术的时间和成本，并最终使更多的患者可以获得这种治疗。Proteios技术公司将提供一个大规模原型，用于在cGMP细胞制造环境中隔离、激活、基因修改、扩展和配制基于细胞的疗法。该项目将为Proteios将用于制造和商业发射的规模原型提供概念证明。在商业化后，Proteios的cGMP仪器将降低基于细胞的治疗制造的成本和时间，并将提供一种可以在患者附近操作的护理点(POC)设备，从而消除了向/从医疗中心实验室传输患者血液样本和所产生的细胞治疗的需要。

Autologous cell-based therapies offer great promise for cancer treatment however they are complex, slow, labor intensive and expensive. Medical center laboratories usually have a limited capacity and they can rarely treat more than 10 patients per month. Advanced manufacturing approaches that can process multiple cell therapies for several patients in parallel are desperately needed to improve the availability of these emerging cell-based therapies. Fully-automated systems would improve the throughput of this technology and are expected to decrease both time and cost of these emerging technologies and ultimately make this treatment available to more patients. Proteios Technology will provide an at-scale prototype to isolate, activate, genetically modify, expand, and formulate cell-based therapies in a cGMP cell manufacturing setting. This project will provide the proof of concept for an at-scale prototype that Proteios will scale for manufacturing and launch commercially. When commercialized, Proteios’ cGMP instrument will reduce both the cost and the time of cell-based therapy manufacturing and will provide a point-of-care (POC) device that can operate near the patient and eliminate the need to transfer patient blood samples and resulting cell therapies to/from medical center laboratories.