Commercialization of clinical grade extracellular vesicles isolated using tangential flow filtration

本计画的目的是探讨一种新型细胞外囊泡制造策略的市场潜力。最近，我们已经表明，从心脏衍生细胞分离的细胞外囊泡可以预防心脏手术后发生的恶性心律疾病，称为心房颤动。但鉴于我们以前的工作仅使用超离心方法分离细胞外囊泡，因此对现实商业翻译的潜力提出了严重的担忧。为了解决这一潜在的限制，我们将我们的技术转变为切向流过滤方法。该系统允许快速处理大量生物流体并分离细胞外囊泡。在这项提案中，我们寻求资金来培训一名学生进行市场分析，以评估这项技术的潜在应用。通过此次培训，我们将仔细探索现有的竞争对手技术，以使我们的创新在市场上处于最佳地位。这一分析将使我们的团队能够根据行业调整我们的商业化和发展战略，并提供相关技能，以与潜在客户和行业利益相关者互动。最终，我们预计该计划将帮助我们为我们的技术确定适当的前进道路，协助制作一个令人信服的推销和开发一个市场评估报告。

The objective of this project is to explore the market potential of a novel extracellular vesicle manufacturing strategy. Recently, we have shown that extracellular vesicles isolated from heart derived cells prevents a malignant heart rhythm condition that occurs after cardiac surgery called atrial fibrillation. But given that our previous work used ultracentrifugation methods alone to isolate extracellular vesicles, serious concerns were raised regarding the potential for realistic commercial translation. To address this potential limitation, we transitioned our technology to a tangential flow filtration methodology. This system allows large volumes of biological fluids to be rapidly processed and extracellular vesicles isolated. In this proposal, we seek funding to train a student to do a market analysis to assess the potential uptake of this technology. With this training, we will carefully explore existing competitor technologies to best position our innovation in the marketplace. This analysis will enable our team to adjust our commercialization and development strategies to the industry and provide relevant skills to engage with potential customers and industry stakeholders. Ultimately, we anticipate this program will help us identify the appropriate path forward for our technology, assist with crafting a compelling pitch and developing a market assessment report.