PFI-TT: Developing next-generation cryopreservation media for natural killer cells

PFI-TT：开发下一代自然杀伤细胞冷冻保存介质

• 批准号: 2042111
• 负责人: Allison Hubel
• 金额: $ 25万
• 依托单位: University of Minnesota-Twin Cities
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2042111&HistoricalAwards=false
• 关键词: PFI; TT; Developing; next; generation

The broader impact/commercial potential of this Partnerships for Innovation - Technology Translation (PFI-TT) project seeks to produce an effective, non-toxic preservation strategies for natural killer (NK)immune cells. NK therapies are composed of living cells that survive for only hours or days outside the body. Without cryopreservation, these therapies can only be administered to a limited number of patients close to the sites of cell collection and manufacturing. As the number of NK cell therapy trials grows, including emerging clinical trials to treat COVID-19, cryopreservation is essential to allow these life-saving therapies to reach a larger number of patients. By enabling cryopreservation of NK therapies, the proposed nkCube product would allow these therapies to be made available off-the-shelf and transported to any hospital or clinic, enabling wider use of this therapy. The nontoxic formulation of nkCube will also facilitate the growth of NK therapies. Cells will be stable in the solution for several hours, allowing for scale-up in batch production, which in turn could decrease the cost of these therapies. While traditional therapies are preserved in a toxic solution that can cause life-threatening side effects, especially in children and smaller patients, nkCube will be formulated with molecules that are safe for human infusion. Overall, the proposed nkCube technology aims to address issues involving the safety, quality and availability of NK therapies, and would allow these therapies to be accessible to a larger population of patients.Currently, the NK cell type survives for only a few hours outside of the body. Current methods of NK preservation result in poor post-thaw tumor killing function, which limits the effectiveness of the treatment. In order to achieve product-market fit, the team will address key hurdles identified in the customer discovery process, including the need to optimize a preservation solution for NK cell survival and function, the need to design a protocol compatible with a variety of workflows, and the need to perform scaled manufacturing and external testing of the final product. This PFI-TT project aims to translate a prototype NK cell preservative into a minimum viable product (nkCube) that meets the needs of NK cell manufacturers. Better methods of preserving these cells may aid in the biomanufacturing of the cells and should reduce the overall cost of producing this type of product. A successful outcome of this study will demonstrate the proof of concept for this preservation process.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这种伙伴关系对创新 - 技术翻译（PFI-TT）项目的更广泛的影响/商业潜力旨在为自然杀手（NK）免疫细胞制定有效的，无毒的保存策略。 NK疗法由活细胞组成，这些细胞仅存活在体外数小时或几天。如果没有冷冻保存，这些疗法只能对靠近细胞收集和制造部位的有限患者进行。随着NK细胞疗法试验的数量的增加，包括新兴的临床试验治疗Covid-19，冷冻保存对于允许这些挽救生命的疗法至关重要。通过实现NK疗法的冷冻保存，拟议的NKCube产品将使这些疗法被现成，并被运送到任何医院或诊所，从而更广泛地使用这种疗法。 NKCube的无毒配方也将促进NK疗法的生长。溶液中的细胞将稳定几个小时，从而可以在批处理生产中扩大规模，从而可以降低这些疗法的成本。尽管传统疗法保存在有毒溶液中，该疗法可能会引起威胁生命的副作用，尤其是在儿童和较小的患者中，但NKCube将使用可安全的人类输注的分子配制。总体而言，拟议的NKCube技术旨在解决涉及NK疗法的安全性，质量和可用性的问题，并允许大量患者可以使用这些疗法。身体。 NK保存的当前方法导致诊断后肿瘤杀死功能不良，这限制了治疗的有效性。为了实现产品市场契合，团队将解决客户发现过程中确定的关键障碍，包括需要优化用于NK单元生存和功能的保存解决方案，需要设计与各种工作流程兼容的协议，并且需要对最终产品进行规模的制造和外部测试。这个PFI-TT项目旨在将原型NK细胞防腐剂转化为最低可行的产品（NKCube），该产品满足NK细胞制造商的需求。 保存这些细胞的更好方法可以有助于细胞的生物制造，并应降低生产此类产品的总体成本。这项研究的成功结果将证明该保存过程的概念证明。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的知识分子优点和更广泛的影响评估标准来评估的。