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，又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，相对于数以千计的加拿大人来说，可用的身体捐赠者太少了，他们可以从这种疗法中受益。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，要使糖尿病的治疗成为现实，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，新的光谱技术可以利用培养细胞的光散射收集关键信息，跟踪干细胞成为胰腺细胞过程中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，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 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.