SBIR Phase II: A high throughput microfluidic platform to accelerate biomanufacturing transitions in biologics development

SBIR II 期：一个高通量微流控平台，可加速生物制剂开发中的生物制造转型

• 批准号: 2309447
• 负责人: Konstantinos Tsioris
• 金额: $ 98.89万
• 依托单位: ONECYTE BIOTECHNOLOGIES, INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2025-08-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2309447&HistoricalAwards=false
• 关键词: SBIR; Phase; II; throughput; microfluidic

The broader/commercial impact of this Small Business Innovation Research (SBIR) Phase II project is accelerating the manufacturing of and access to newly developed therapeutics and vaccines. To address global health problems, effective and safe new biologics such as therapeutics and vaccines will need to be manufactured at unprecedented large scales and short times. Accelerating access to new biologics for potentially billions of individuals will be critical for healthcare and the global economy. The solutions will be manifold, and realizing productive and robust manufacturing for these candidate preventative and therapeutic medicines in a short period of time remains a key challenge to transition discoveries from the lab to the clinic. The innovations proposed in this project could significantly accelerate drug development and biologics manufacturing by shortening the biologics development times up to six months. Vaccine and drug developers would succeed faster and fail faster, enabling accelerated transitions of discoveries for new therapeutics to the clinic and beyond by addressing critical steps in manufacturing. Improving transitions should also let developers test a higher number of compounds, thereby increasing the performance and potentially reducing the side effects of these drugs.This project aids in the manufacturing of novel therapeutics and vaccines. Manufacturing of biologics starts with a high-performing clonal cell-line, derived (by definition) from a single cell. Developing such a cell line today takes up to six months due to the iterative screening and testing needed to assure quality and performance. This essential step in any biologic manufacturing transition is critical time lost in the fight against disease. This project enables drug developers to select a high-performing cell clone in one day, compared to many months by using a proprietary, single-cell, proteomics platform at an unprecedented throughput rather than having to go through lengthy, iterative selection, clonal expansion and analytics. The scope of the research is focused on addressing the remaining critical technical hurdles before deploying the technology for commercial use. Specifically, a systematic and statistical approach will be used to implement necessary alternative materials and processes. The goal of the project will be implementing the developed processes with biotechnology industry partners to accelerate vaccine and therapeutic development and manufacturing.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.

这项小型企业创新研究（SBIR）第二阶段项目的更广泛/商业影响正在加速并获得新开发的治疗疗法和疫苗。为了解决全球健康问题，有效且安全的新生物制剂（例如治疗剂和疫苗）将需要在前所未有的大规模和短时间内生产。加速潜在的数十亿个人获得新生物制剂的机会对于医疗保健和全球经济至关重要。这些解决方案将是多种多样的，并在短时间内为这些候选者预防和治疗药物实现生产性和健壮的制造，仍然是从实验室到诊所的过渡发现的关键挑战。该项目提出的创新可以通过将生物制剂开发时间缩短到六个月来显着加速药物开发和生物制造。疫苗和药物开发人员将成功更快，更快地失败，从而通过解决制造业的关键步骤，从而加速了新疗法的发现过渡到诊所。改进的过渡还应使开发人员测试更高数量的化合物，从而提高性能并潜在地减少这些药物的副作用。该项目有助于制造新型的治疗剂和疫苗。生物制剂的制造始于高性能的克隆细胞系，该细胞系（根据定义）从单个细胞中得出。由于迭代筛查和测试需要确保质量和性能，因此今天开发这种细胞系列最多需要六个月。任何生物制造过渡的基本步骤都是在打击疾病的斗争中丧失的关键时间。该项目使药物开发人员能够在一天之内选择一个高性能的细胞克隆，而多个月来，通过在前所未有的吞吐量上使用专有的单细胞，蛋白质组学平台，而不必经过冗长的，迭代的选择，克隆扩张和分析。该研究的范围侧重于解决剩余的关键技术障碍，然后再部署该技术以供商业用途。具体而言，系统和统计方法将用于实施必要的替代材料和过程。该项目的目的是通过生物技术行业合作伙伴实施开发的过程，以加速疫苗和治疗性开发和制造业。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审查标准通过评估来进行评估的。