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

主题 429 - 自体和同种异体细胞治疗制造的新范式 (SBIR)

• 批准号: 10610298
• 负责人: BOB SNYDER
• 金额: $ 5.5万
• 依托单位: PROTEIOS TECHNOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-13 至 2022-06-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10610298
• 关键词: Allogenic; Antibodies; Autologous; Benchmarking; Blood; CAR T cell therapy; CD4 Positive T Lymphocytes; CD8B1 gene; Cell Separation; Cell Therapy; Cells; Chimera organism; Cyclic GMP; Engineering; Formulation; Growth; Health Care Costs; Immobilized Cells; Methods; NK cell therapy; Natural Killer Cells; Peripheral Blood Mononuclear Cell; Phase; Preparation; Production; Research; Research Personnel; Small Business Innovation Research Grant; Specificity; Speed; T-Lymphocyte; Technology; Testing; Vision; cell growth; cost; flexibility; gene therapy; immune function; instrument; magnetic beads; novel strategies; prototype; scale up; transduction efficiency

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.

Proteios技术已经开发了一个专有的平台，该平台不依赖抗体或磁珠来分离细胞亚群。该平台已使用CD4+和CD8+亚群在T细胞上进行了验证，以生产自体CAR-T细胞疗法。他们目前正在扩展平台，用于隔离天然杀手（NK）细胞以生产自体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构建基准原型，以验证其平台的规模，以生产CAR-T细胞疗法并针对当前的制造方法进行基准测试。 Proteios的模块化方法将提供灵活性，以适应细胞疗法的新方法，因为研究人员能够通过其研究工具分离新的细胞亚群。 Proteios的愿景是继续构建尺度CGMP原型，并应用其技术来帮助降低包括细胞疗法和基因疗法在内的医疗保健疗法成本。