Development of a platform for tracking the stability of advanced BioTherapeutics

生物制药的稳定性一直是一个关键的问题，因为药物由于安全问题而被从市场上撤下，几乎没有努力取代它们。因此，为了了解围绕大型生物制品的稳定性问题，该项目涉及监测各种影响稳定性的因素下的稀土效应。红边激发漂移(REES)是一种通过激发荧光团朝向可见光光谱的红边并检测荧光团的荧光发射而获得的一种荧光方法。通过这样做，人们可以深入了解蛋白质的动力学和结构。将使用荧光光谱仪测量各种生物制药，如病毒载体、外切体和单抗。因此，将使用AFM、TEM、DLS和DSC等正交方法进一步支持这一结果，以验证REES的发现。

Biopharmaceutical stability has been a critical concern as drugs are being taken off the market due to safety issues with little to no effort in replacing them. Hence, with the aim of understanding the stability issues surrounding large biologics, this project involves monitoring the REES effect under various factors affecting stability. Red Edge Excitation Shift (REES) is a fluorescence method that is obtained by exciting the fluorophore towards the red edge of the visible light spectrum and detecting the fluorescence emission from the fluorophore. In doing so one can gain insight into protein dynamics and structure. Various biopharmaceuticals will be measured such as viral vectors, exosomes and monoclonal antibodies using a fluorescence spectrometer. The results will thus be further supported using orthogonal methods such as AFM, TEM, DLS and DSC to verify the findings of REES.