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

新兴的细胞疗法既有可能极大地改善个人健康**，也有可能通过治愈疾病来降低医疗成本。例如，已经确定一种细胞移植疗法可以逆转并有可能治愈1型糖尿病。然而，相对于成千上万可以从这种疗法中受益的加拿大人来说，可用的身体捐赠者实在太少了。从**培养的干细胞中生成胰岛(胰岛素生成细胞)是一项令人兴奋的发展，可以为糖尿病患者的移植提供基本上无限的**供应。已经在动物模型中证明了这些**细胞可以逆转糖尿病，目前正在进行人类临床试验。**然而，要使糖尿病的治愈成为现实，必须克服几个挑战。**其中，改善用于生产这些细胞的复杂过程是最重要的。**例如，我们需要能够对培养物进行非侵入性(和非接触)监测的技术，以便生产的细胞保持安全和有效。我们的团队已经**证明了新的光谱技术可以利用培养细胞的光散射**来收集关键信息，跟踪干细胞**成为胰腺细胞**时发生的关键发育变化。该项目将推进这项非侵入性技术，使其能够**用于评估和控制用于**移植的干细胞来源的治疗细胞的质量。这将有助于开发和批准安全有效的**疗法，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**疾病的细胞疗法，如癌症和心脏病的细胞疗法。

Emerging cellular therapies have the potential to both greatly improve the health of individuals**and to reduce healthcare costs by curing diseases. For example, it has been established that**a cellular transplant therapy can reverse and potentially cure type 1 diabetes. However, there**are far too few cadaveric donors available relative to the many thousands of Canadians who**could benefit from this therapy. Generating pancreatic islets (insulin-generating cells) from**cultured stem cells is an exciting development that could provide an essentially unlimited**supply for transplantation into diabetic patients. It has already been demonstrated that these**cells 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 has**shown that novel spectroscopic techniques can gather critical information using light scattered**by the cultured cells, tracking the critical developmental changes taking place as stem cells**become pancreatic cells. This project will advance this non-invasive technology so that it can**be used to assess and control the quality of stem cell-derived therapeutic cells destined for**transplantation. This will contribute to the development and approval of safe and efficacious**therapies with the potential of curing thousands of Canadians. While the first application will**target diabetes, our technology could also be applied to many other cell therapies that target**diseases such as cancer and heart disease cellular therapy.