Simple and Effective Method for Cell Separation During Preclinical Research and Cell Therapy Manufacturing

临床前研究和细胞疗法制造过程中简单有效的细胞分离方法

• 批准号: 10549233
• 负责人: Bob Snyder
• 金额: $ 81.64万
• 依托单位: PROTEIOS TECHNOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10549233
• 关键词: Allogenic; Antibodies; Area; Autologous; Automation; Award; Binding; Biological Products; Biotechnology; CAR T cell therapy; Cell Separation; Cell Therapy; Cells; Chemistry; Child; Chimera organism; Clinical; Clinical Research; Clinical Trials; Cyclic GMP; Development; Devices; Differentiation Antigens; Disease; Drug Industry; Explosion; Feedback; Fred Hutchinson Cancer Research Center; Goals; Health Care Costs; Individual; Innovation Corps; Interview; Life; Malignant Neoplasms; Medicine; Methods; Nucleic Acids; Patients; Persons; Pharmaceutical Preparations; Pharmacy facility; Phase; Physicians; Process; Production; Proteins; Reagent; Recombinant Antibody; Recombinant Proteins; Research; Research Institute; Research Personnel; Savings; Scientist; Services; Small Business Innovation Research Grant; Source; Specificity; Supporting Cell; Technology; Therapeutic; Time; United States National Institutes of Health; University of Texas M D Anderson Cancer Center; Viral Vector; Virus; aptamer; base; cancer therapy; cell injury; cell type; chimeric antigen receptor T cells; cohort; college; cost; cost effective; instrument; leukemia treatment; leukemia/lymphoma; novel therapeutics; oxidative damage; pre-clinical; pre-clinical research; prescription drug costs; product development; protein biomarkers; research and development; small molecule; therapy development; tool

Project Summary Proteios is an emerging startup driven to reduce the rising cost of healthcare. Prescription drug costs are the fastest rising component and are contributing to the dramatic increase in healthcare costs. The worldwide focus of pharmacy and biotechnology is now in two areas: 1) biopharmaceutical development and production and 2) cell therapies. Cell therapies have demonstrated enormous promise for transforming the treatment of cancer and other debilitating diseases, and the FDA has already approved their use for the treatment of leukemia and lymphoma. However, some cell therapies can cost as much as $350,000 per treatment, which has made these life-saving technologies inaccessible to many patients. The objective of this proposal is to provide Preclinical Researchers with a simple and cost-effective cell separation tool to isolate and study cell subpopulations for their potential use as new cell therapeutics. Proteios’ cell separation technology will also be employed during cell therapy manufacturing; Proteios will develop cell separation cartridges for use with its cGMP cell therapy manufacturing instrument currently under development. Our goal for Phase II of the SBIR award is to develop new Proteios Chimeras for the 15 most commonly studied cell subpopulations used for autologous and allogeneic cell therapies. Chimeras form a critical component of the Proteios Chimera Platform that will empower our Preclinical Research R&D cell separations kits and cell separation cartridges for Manufacturing. The platform provides a tag-free, antibody-free isolation platform based on proprietary protein technology and nucleic acid aptamers by immunoaffinity capture of cells that express Cluster of Differentiation (CD) marker proteins. Our approach avoids challenging and costly steps where antibodies or other proteins are covalently modified to bind to beads or small molecules. Additionally, our approach eliminates commonly used reagents that cause oxidative damage to cells. When commercialized, this approach will alleviate some of the concerns with current technologies - such as high cost, long development times, lack of automation and clinical-grade reagents, and complicated, multistep chemistry. The development of products for cell isolation using the Proteios Chimera Platform has the potential to reduce the cost of cell separations by more than tenfold. Furthermore, this technology could transform the production process for therapeutic cells to make life-saving cell therapies available to more individuals.

项目摘要 Proteios是一种新兴的创业驱动力，可降低医疗保健成本上升。处方药成本是 最快上升的组成部分，并为医疗保健成本的急剧增长做出了贡献。全球关注的焦点 现在的药房和生物技术现在有两个领域：1）生物制药的发展和生产和2） 细胞疗法。细胞疗法表现出了转化癌症治疗的巨大希望 以及其他令人衰弱的疾病，FDA已经批准用于治疗白血病和 淋巴瘤。但是，某些细胞疗法每次治疗的费用高达35万美元，这使得 许多患者无法获得生命的技术。该提议的目的是提供临床前 具有简单且具有成本效益的细胞分离工具的研究人员，以分离和研究细胞亚群 潜在用作新细胞疗法。 Proteios的细胞分离技术也将在细胞期间采用 治疗制造； ProteIOS将开发用于其CGMP细胞疗法的细胞分离墨盒 目前正在开发的制造工具。 我们获得SBIR奖第二阶段的目标是为15个最常见的研究生长开发新的Proteios Chimeras 用于自体和同种异体细胞疗法的细胞亚群。嵌合体形成了关键组成部分 Proteios Chimera平台将授权我们的临床前研究研发细胞分离套件和细胞 用于制造的分离墨盒。该平台提供了基于无标签的无抗体隔离平台 关于专有蛋白质技术和核酸适体，通过免疫亲和力捕获表达的细胞 分化簇（CD）标记蛋白。我们的方法避免了挑战和昂贵的步骤 抗体或其他蛋白质经过共价修饰以结合珠或小分子。另外，我们的 方法消除了对细胞造成氧化损伤的常用试剂​​。 当商业化时，这种方法将减轻当前技术的一些问题 - 例如 成本，长期开发时间，缺乏自动化和临床级试剂以及复杂，多步骤 化学。使用Proteios Chimera平台开发用于细胞分离的产品具有潜力 将细胞分离的成本降低超过十倍。此外，这项技术可以改变 热细胞使更多个体可用的挽救生命的细胞疗法的生产过程。