Bioassay Development Lead Bill & Melinda Gates Medical Research Institute Cambridge, Massachusetts
In this study we evaluated the utility and performance of capillary blood microsampling to measure monoclonal antibody concentration and functional neutralization activity. Extracted samples demonstrated good performance and exhibited concordance to concentrations from serum-derived samples. Moreover, extracted dried blood microsample also retained viral neutralizing activity that correlated with serum-derived samples from the same study participants. These results further support the potential application of capillary blood microsampling in clinical development.
Learning Objectives:
Support the feasibility of replacing serum with patient-centric approaches collecting dried blood
Describe the similarities and differences in data sets generated from serum and dried blood for an individual monoclonal antibody
Reassess the risk tolerance of their organization and identify potential next steps towards patient-centric sampling in their own trials