Development of a platform for tracking the stability of advanced BioTherapeutics

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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.