Innovation of Biobanking for Cellular Adoptive Immunotherapies Based on a First-in-Class Biocompatible Cryopreservation Technology for T and NK Cells and Their CAR-Engineered Products

总结 先前来自NIH SBIR和库尔特基金会的支持使CryoCrate团队能够开发出第一个- 不需要任何细胞渗透和毒性的同类生物相容性冷冻保存介质产品 冷冻保护剂该产品的商标为OdinSol®，并已被批准提供显著的 提高了对基于细胞的过继性免疫疗法至关重要的细胞类型的冷冻储存效率。的 OdinSol®技术还消除了对血清和人类产品的需求，并确保长期储存 在-80 ° C的冷冻箱中。 根据我们之前在FDA 510（k）提交方面的经验，在本项目中，我们组织了与 我们的监管顾问（Cardinal Health）、合同生产组织（Bryllan）、合同研究 组织（WuXi AppTec），学术合作伙伴（大学精准医学中心） （密苏里州），以实现以下里程碑： I. OdinSol®的生产符合GMP资格和生物相容性评估表明 符合FDA 510（k）提交指南，作为可拆卸电池的存储设备; 二.安全性和有效性的体外和体内评价证明OdinSol®技术是 在保存活力和功能性方面上级现有的低温保存方案 T、NK和CAR-T细胞; 三.根据这些资格，我们将完成510（k）提交并完成生产 在项目期结束前，根据林业发展局的进一步反馈， 我们预计OdinSol®技术将在FDA批准后三年内投入临床使用， 细胞治疗行业的一个高效的生物相容性冷冻储存平台。

SUMMARY Previous support from NIH SBIR and Coulter Foundation awards allowed the CryoCrate team to develop a first- in-class biocompatible cryopreservation medium product that doesn’t need any cell permeating and toxic cryoprotectant. The product is trademarked as OdinSol®, and has been approved to provide significantly improved efficiency in cryostorage of cell types that are essential for cell-based adoptive immunotherapies. The OdinSol® technology also removes the requirement of serum and human products and secures long-term storage in regular -80oC deep freezers. Based on our former experience in FDA 510(k) submission, in this project, we organized the collaboration with our regulatory consultant (Cardinal Health), contract manufacturing organizations (Bryllan), contract research organization (WuXi AppTec), academic subcontract collaborator (the Center for Precision Medicine at University of Missouri), to achieve the following milestones: I. The production of OdinSol® meets GMP qualifications and biocompatibility assessment shows compliance with FDA guidance for 510(k) submission as a storage device for transfusable cells; II. The in vitro and in vivo evaluation of safety and efficacy demonstrates the OdinSol® technology to be superior to existing cryopreservation protocols with respect to preserving viability and functionalities of T, NK and CAR-T cells; III. Based on those qualifications, we will complete of the 510(k) submission and finalize of the production line based on further FDA feedback before the end of the project period. We expect future clinical use of the OdinSol® technology within three years after the FDA clearance, providing the industry of cell therapies with a highly efficient biocompatible cryostorage platform.