权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

SBIR Phase I: Automated Closed Systems for Manufacturing Autologous Dendritic Cell Therapies

SBIR 第一阶段：用于制造自体树突状细胞疗法的自动化封闭系统

基本信息

批准号：
1819306
负责人：
Jennifer Rossi
金额：
$ 22.5万
依托单位：
FLASKWORKS
依托单位国家：
美国
项目类别：
Standard Grant
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-01 至 2018-12-31
项目状态：
已结题

来源：
https://www.nsf.gov/awardsearch/showAward?AWD_ID=1819306&HistoricalAwards=false
关键词：
SBIR Phase Automated Closed Systems

项目摘要

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project is in the development of new technologies to manufacture personalized therapies for cancer and other diseases that are based on a patient's own cells. Such therapies have shown remarkable success in recent years, however, manufacturing these therapies is challenging because mass production techniques cannot be employed when each patient receives a unique therapy. Indeed, for therapies based on dendritic cells, which are an important part of the human immune system, there are no manufacturing systems currently available that can perform all of the required steps. This project will address this major unmet need by leveraging advanced concepts in engineering and biology to design an integrated system for cost-effective manufacturing of dendritic cell therapies. Given the large number of personalized cell-based therapies currently in clinical trials, and recently approved therapies, such a system is expected to address a major societal need and have significant commercial potential. This SBIR Phase I project proposes to develop a manufacturing system to cover the steps involved in the manufacturing of autologous dendritic cell therapies. Because of the low abundance of these cells in blood, dendritic cells are typically generated from blood-derived monocytes. Following differentiation of monocytes into dendritic cells, these cells are then matured and stimulated with tumor-specific antigens. These steps represent discrete unit operations that require a system capable of handling both adherent and non-adherent cell types, different reagents for each step, and the ability to transition from one step to another with minimal loss of cells. Further, all steps must be performed in a disposable single-use enclosure. In order to achieve automation and integration of these steps, the proposed system will leverage innovations in perfusion-based dendritic cell culture and novel and cost-effective bioreactor design strategies. A combination of computational modeling and rapid-prototyping techniques will be employed for rapid iteration of prototypes and testing with potential users involved in therapeutic development. Successful completion of this project will result in feasibility demonstration of an integrated manufacturing system developed with significant end user feedback.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.

这个小企业创新研究（SBIR）项目的更广泛的影响/商业潜力在于开发新技术，以基于患者自身细胞制造癌症和其他疾病的个性化疗法。近年来，这种疗法取得了显著的成功，然而，制造这些疗法是具有挑战性的，因为当每个患者接受独特的疗法时，无法采用大规模生产技术。事实上，对于基于树突状细胞的疗法，这是人类免疫系统的重要组成部分，目前还没有可以执行所有所需步骤的制造系统。该项目将通过利用工程和生物学的先进概念来解决这一主要未满足的需求，以设计一个具有成本效益的树突状细胞疗法制造集成系统。鉴于目前在临床试验中的大量个性化细胞疗法以及最近批准的疗法，预计这样的系统将满足主要的社会需求并具有显著的商业潜力。该SBIR I期项目旨在开发一种生产系统，以涵盖自体树突状细胞疗法生产中涉及的步骤。由于这些细胞在血液中的丰度低，树突状细胞通常由血液来源的单核细胞产生。在单核细胞分化成树突细胞后，这些细胞然后成熟并用肿瘤特异性抗原刺激。这些步骤代表离散的单元操作，其需要能够处理粘附和非粘附细胞类型的系统、用于每个步骤的不同试剂以及以最小的细胞损失从一个步骤过渡到另一个步骤的能力。此外，所有步骤必须在一次性使用的外壳中进行。为了实现这些步骤的自动化和集成，所提出的系统将利用基于灌注的树突状细胞培养的创新和新颖且具有成本效益的生物反应器设计策略。计算建模和快速原型技术的组合将用于原型的快速迭代和与参与治疗开发的潜在用户的测试。该项目的成功完成将导致一个集成制造系统的可行性论证开发与显着的最终用户的反馈。这个奖项反映了NSF的法定使命，并已被认为是值得的支持，通过评估使用基金会的智力价值和更广泛的影响审查标准。