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

基于 T 细胞和 NK 细胞及其 CAR 工程产品的一流生物相容性冷冻保存技术的细胞过继免疫疗法生物库创新

基本信息

  • 批准号:
    10611789
  • 负责人:
  • 金额:
    $ 89.89万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2022
  • 资助国家:
    美国
  • 起止时间:
    2022-09-15 至 2024-08-31
  • 项目状态:
    已结题

项目摘要

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.
概括 NIH SBIR和COULTER基金会奖的先前支持使得6级授予团队能够开发一个第一 需要任何细胞渗透和有毒的阶层生物相容性的冷冻保存培养基 冷冻保护剂。 提高了基于细胞基于细胞的产物IM Simmunotherapies的细胞类型低温稳态的效率。 Odinsol®技术还取消了血清和人类产品以及安全性长期存储的需求 在常规的-80oc深冰柜中。 根据我们以前在FDA 510(k)提交中的经验,在此项目中,我们与之合作。 我们的监管顾问(Cardinal Health),合同制造组织(Bryllan),合同研究 组织(Wuxi Apptec),学术分包合作者(大学精密医学中心 密苏里州),实现以下里程碑: I.Odinsol®的生产符合GMP资格和生物兼容性评估表明 符合510(k)提交的FDA指南作为可容纳单元的存储设备; II。 在保持生存能力和功能方面,优于现有的冷冻保存协议 t,nk和car-t细胞; iii。 在项目期结束之前基于FDA反馈的行。 我们希望未来的临床用途Odinsol®技术在FDA清除后三个三个三个三个中 具有高效的生物相容性低温固化平台的细胞疗法行业。

项目成果

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Xu Han其他文献

Xu Han的其他文献

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{{ truncateString('Xu Han', 18)}}的其他基金

Innovation of Skin Banking and Transplantation Based on a First-in-Class Biocompatible Cryopreservation Technology
基于一流的生物相容性冷冻保存技术的皮肤库和移植创新
  • 批准号:
    10618957
  • 财政年份:
    2022
  • 资助金额:
    $ 89.89万
  • 项目类别:
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
基于 T 细胞和 NK 细胞及其 CAR 工程产品的一流生物相容性冷冻保存技术的细胞过继免疫疗法生物库创新
  • 批准号:
    10705271
  • 财政年份:
    2022
  • 资助金额:
    $ 89.89万
  • 项目类别:
Late-stage Preclinical Development and cGMP Production of a First-in-Class Cornea Cryopreservation Kit Based on FDA Feedback
根据 FDA 反馈,对一流的角膜冷冻保存试剂盒进行后期临床前开发和 cGMP 生产
  • 批准号:
    10326323
  • 财政年份:
    2021
  • 资助金额:
    $ 89.89万
  • 项目类别:
A Novel Cryopreservation Technology for Large Skin Grafts to Facilitate Tissue Banking and Allograft Transplantations
一种用于大型皮肤移植物的新型冷冻保存技术,以促进组织库和同种异体移植
  • 批准号:
    10011745
  • 财政年份:
    2020
  • 资助金额:
    $ 89.89万
  • 项目类别:
An Ultra-fast Cooling Device for Vitrification and Cryopreservation of Cells and Tissues
用于细胞和组织玻璃化和冷冻保存的超快速冷却装置
  • 批准号:
    10221208
  • 财政年份:
    2015
  • 资助金额:
    $ 89.89万
  • 项目类别:
An Ultra-fast Cooling Device for Vitrification and Cryopreservation of Cells and Tissues
用于细胞和组织玻璃化和冷冻保存的超快速冷却装置
  • 批准号:
    10006333
  • 财政年份:
    2015
  • 资助金额:
    $ 89.89万
  • 项目类别:
An Ultra-fast Cooling Device for Vitrification and Cryopreservation of Cells and Tissues
用于细胞和组织玻璃化和冷冻保存的超快速冷却装置
  • 批准号:
    8834867
  • 财政年份:
    2015
  • 资助金额:
    $ 89.89万
  • 项目类别:

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解码表观遗传景观,描绘 T 细胞稳态增殖与不受控制的生长 –
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