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

项目摘要 Proteios是一家新兴的初创公司，旨在降低不断上升的医疗成本。处方药成本是 这是增长最快的组成部分，也是医疗成本急剧上升的原因之一。全球关注的焦点 制药和生物技术目前在两个领域：1)生物制药的开发和生产；2) 细胞疗法。细胞疗法已显示出改变癌症治疗的巨大前景。 和其他使人衰弱的疾病，FDA已经批准它们用于治疗白血病和 淋巴瘤。然而，一些细胞疗法的每次治疗费用可能高达35万美元，这使得这些 挽救生命的技术对许多患者来说是无法获得的。这项提案的目标是提供临床前 研究人员使用一种简单且经济高效的细胞分离工具来分离和研究细胞亚群 作为新的细胞疗法的潜在用途。Proteios的细胞分离技术也将在细胞 治疗制造；Proteios将开发用于其cGMP细胞治疗的细胞分离盒 目前正在开发的制造仪器。 SBIR奖第二阶段的目标是为15个最常见的研究开发新的Proteios嵌合体 用于自体和异体细胞治疗的细胞亚群。嵌合体形成了 Proteios嵌合体平台将支持我们的临床前研究、研发、细胞分离试剂盒和细胞 用于制造的分离盒。该平台提供了一个无标签、无抗体的分离平台 通过免疫亲和捕获表达的细胞的专有蛋白质技术和核酸适配子 分化簇(CD)标记蛋白。我们的方法避免了具有挑战性且代价高昂的步骤 抗体或其他蛋白质被共价修饰以结合到珠子或小分子上。此外，我们的 该方法消除了对细胞造成氧化损伤的常用试剂。 当商业化后，这种方法将缓解对当前技术的一些担忧--例如高 成本高，开发周期长，缺乏自动化和临床级试剂，而且复杂，多步骤 化学反应。利用Proteios嵌合体平台开发细胞分离产品具有潜力 将细胞分离的成本降低十倍以上。此外，这项技术可以改变 治疗性细胞的生产过程，使更多的人可以获得挽救生命的细胞疗法。

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.