Bioanalytics – Biomolecular
2019 PharmSci 360
There are increased publications reporting that exosomes may drive relevant features associated with cancer progression. A recent article published in Cell reported that the suppression of exosomal PD-L1 induces systemic anti-tumor immunity and memory. In addition, tumor- or immuno-cells derived exosomal biomarkers have been suggested as predictive and prognostic biomarkers for monitoring the results of treatment in cancers. As a result, there is a need in the bioanalytical community to understand the bioanalytical considerations of measuring exosome-based biomarkers
Traditionally, plasma and other body fluid samples have been used to mesure soluble molecule biomarkers and therapeutics. The regulatory bioanalytical guidelines and industry best practices have been mainly developed to address the needs for measuring soluble molecules. The exosomes are complex nanoparticles and require special sample preparation to separate them from soluble molecules.
The presentation will provide an overview on exosome biology, preparation and assay methods, and examples of biomarker uses. Case studies will be discussed on the bioanalytical considerations including those for both exosome preparations and analytical method development. The information will not only help bioanalytical scientists to develop methods for this emerging sample type, but also help regulatory agencies to develop guidance. Furthermore, it will help data users to best interpret the results.