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

SBIR 第二阶段，主题 429：自体和同种异体细胞治疗制造的新范式

基本信息

批准号：
10976161
负责人：
BOB SNYDER
金额：
$ 105万
依托单位：
PROTEIOS TECHNOLOGY, INC.
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-15 至 2025-09-14
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10976161
关键词：
SBIR PHASE II TOPIC 429

SBIR PHASE II TOPIC 429

项目摘要

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.

基于自体细胞的疗法为癌症治疗提供了巨大的希望，但是它们复杂，缓慢，劳动密集型和昂贵。医疗中心实验室的容量通常有限，他们每月很少对10名患者进行治疗。迫切需要对几名并行的几名患者进行多种细胞疗法的高级制造方法，以提高这些新兴细胞的疗法的可用性。完全自动化的系统将改善该技术的吞吐量，并有望降低这些新兴技术的时间和成本，并最终使更多患者可以使用这种治疗方法。 Proteios技术将提供一个尺度原型，以在CGMP细胞制造环境中隔离，激活，一般修改，扩展和制定基于细胞的疗法。该项目将为一个规模的原型提供概念证明，该原型将在商业上进行制造和推出。当商业化时，Proteios的CGMP仪器将减少基于细胞的治疗制造的成本和时间，并提供可以在患者附近运行的护理点（POC）设备，并消除了转移患者血液样本以及由医疗中心实验室进行的细胞疗法的必要性。