SBIR TOPIC 445- ADVANCED MANUFACTURING TO SPEED AVAILABILITY OF EMERGING AUTOLOGOUS CELL-BASED THERAPIES

SBIR 主题 445 - 先进制造加速新兴自体细胞疗法的可用性

• 批准号: 10701477
• 负责人: MARK STASIAK
• 金额: $ 40万
• 依托单位: ELATE MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2023-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10701477
• 关键词: Autologous; Back; Benchmarking; Biological Assay; Blood; Cell Culture Techniques; Cell Density; Cell Separation; Cell Therapy; Cells; Clinical Protocols; Collection; Cryopreservation; Devices; Environment; Freezing; Glucose; Goals; Human Resources; Magnetism; Maintenance; Monitor; Oxygen; Performance; Pharmaceutical Preparations; Phase; Process; Sampling; Shipping; Ships; Site; Small Business Innovation Research Grant; Speed; System; T cell therapy; T-Lymphocyte; Time; Training; Translations; Walking; chimeric antigen receptor T cells; cost; design; glucose monitor; improved; innovation; manufacturing process; microbial; operation; point of care; prototype; transgene expression; treatment site

Current practice of T cell therapy drug manufacturing involves collection, shipment of the blood to a manufacturing site, manufacturing of the drug in a cleanroom environment by a trained technologists, analytical assays for drug release, and the final shipment of frozen product back to the treatment site. The cost and time involved in manufacturing process, analytical assays, and a regulatory approval create a huge bottleneck to rapid translation of early phase, innovative products. Our long-term objective is to develop a device (EM01) that can implement a point of care walk-away operation to significantly simplify the cost, time, and a regulatory approval of the cell therapy manufacturing. EM01 will be designed to eliminate cryopreservation and shipping of incoming material and final product, to operate in a non-cleanroom environment by minimally trained personnel, and to integrate automated analytical assay system. Specific to this proposal, we will build a prototype integrated cell culture chamber and flow guide with in-chamber cell isolation and for in-process monitoring of glucose, oxygen, cell density, transgene expression, and microbial assays. Cell products manufactured from the prototype will then be benchmarked against the CAR T products manufactured following a clinical protocol using CliniMACS Prodigy system.

目前T细胞治疗药物生产的实践包括收集血液、将血液运送到生产地点、由训练有素的技术人员在洁净室环境中生产药物、药物释放的分析测定以及最终将冷冻产品运送回治疗地点。制造过程、分析测定和监管批准所涉及的成本和时间产生了巨大的风险。 瓶颈，以快速翻译早期阶段，创新产品。我们的长期目标是开发一种设备（EM01），可以实现护理点的步行操作，以显着简化成本，时间和细胞治疗制造的监管批准。EM01的设计旨在消除来料和最终产品的冷冻保存和运输，由经过最低限度培训的人员在非洁净室环境中操作，并集成自动化分析测定系统。具体到这个提案，我们将建立一个原型集成细胞培养室和导流与室内细胞分离，并在过程中监测葡萄糖，氧气，细胞密度，转基因表达和微生物测定。然后，将使用CliniMACS Prodigy系统根据临床方案制造的CAR T产品对原型制造的细胞产品进行基准测试。