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

这一小型企业创新研究（SBIR）第二阶段项目的更广泛/商业影响正在加速新开发的疗法和疫苗的生产和获得。为了解决全球健康问题，需要在前所未有的大规模和短时间内生产有效和安全的新生物制剂，如治疗剂和疫苗。加速潜在数十亿人获得新生物制剂对医疗保健和全球经济至关重要。解决方案将是多种多样的，在短时间内实现这些候选预防和治疗药物的生产和稳健制造仍然是将发现从实验室转移到临床的关键挑战。该项目中提出的创新可以通过将生物制剂的开发时间缩短至6个月来显著加快药物开发和生物制剂的生产。疫苗和药物开发人员将更快地成功，更快地失败，通过解决制造中的关键步骤，使新疗法的发现加速过渡到临床和其他领域。改进转换也应该让开发人员测试更多的化合物，从而提高性能，并可能减少这些药物的副作用。该项目有助于制造新的治疗药物和疫苗。生物制品的生产始于高性能的克隆细胞系，其来源于（根据定义）单细胞。今天，开发这样的细胞系需要长达六个月的时间，因为需要反复筛选和测试以确保质量和性能。任何生物制造转型中的这一关键步骤都是在与疾病作斗争中失去的关键时间。该项目使药物开发人员能够在一天内选择一个高性能的细胞克隆，而不是通过使用专有的单细胞蛋白质组学平台以前所未有的通量进行数月，而不必经历漫长的迭代选择，克隆扩增和分析。研究范围的重点是在将该技术用于商业用途之前解决剩余的关键技术障碍。具体而言，将采用系统和统计方法实施必要的替代材料和工艺。该项目的目标是与生物技术行业合作伙伴一起实施已开发的流程，以加速疫苗和治疗药物的开发和制造。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.