Raman Spectroscopy Analysis to Improve the Validation of Cell Therapy Manufacturing Processes

新兴的细胞疗法有可能极大地改善个人的健康状况，并通过治疗疾病来降低医疗成本。例如，已经确定细胞移植疗法可以逆转并有可能治愈1型糖尿病。然而，相对于可以从这种疗法中受益的成千上万的加拿大人来说，可用的尸体捐献者太少了。从培养的干细胞中产生胰岛（产生胰岛素的细胞）是一项令人兴奋的进展，它可以为糖尿病患者的移植提供基本上无限的供应。在动物模型中已经证明这些细胞可以逆转糖尿病，目前正在进行人体临床试验。然而，要使这种治疗糖尿病的方法成为现实，还必须克服若干挑战。其中，改进用于生产这些细胞的复杂过程是至关重要的。例如，我们需要能够对培养物进行无创（无接触）监测的技术，以使所产生的细胞保持安全和有效。我们的团队已经证明，新的光谱技术可以利用培养细胞散射的光收集关键信息，跟踪干细胞成为胰腺细胞时发生的关键发育变化。该项目将推进这种非侵入性技术，使其可用于评估和控制用于移植的干细胞衍生治疗细胞的质量。这将有助于开发和批准安全有效的治疗方法，有可能治愈成千上万的加拿大人。虽然第一个应用将针对糖尿病，但我们的技术也可以应用于许多其他针对癌症和心脏病等疾病的细胞治疗。

Emerging cellular therapies have the potential to both greatly improve the health of individualsand to reduce healthcare costs by curing diseases. For example, it has been established thata cellular transplant therapy can reverse and potentially cure type 1 diabetes. However, thereare far too few cadaveric donors available relative to the many thousands of Canadians whocould benefit from this therapy. Generating pancreatic islets (insulin-generating cells) fromcultured stem cells is an exciting development that could provide an essentially unlimitedsupply for transplantation into diabetic patients. It has already been demonstrated that thesecells can reverse diabetes in animal models, and a human clinical trial is currently underway.However, several challenges must be overcome to make this cure for diabetes a reality.Among them, improving the complex processes used to produce these cells is paramount.For example, we need technologies capable of non-invasively (and without contact)monitoring of the cultures so that the cells produced remain safe and effective. Our group hasshown that novel spectroscopic techniques can gather critical information using light scatteredby the cultured cells, tracking the critical developmental changes taking place as stem cellsbecome pancreatic cells. This project will advance this non-invasive technology so that it canbe used to assess and control the quality of stem cell-derived therapeutic cells destined fortransplantation. This will contribute to the development and approval of safe and efficacioustherapies with the potential of curing thousands of Canadians. While the first application willtarget diabetes, our technology could also be applied to many other cell therapies that targetdiseases such as cancer and heart disease cellular therapy.