Points to Consider in the Development of Activity and Potency Assays for Enzyme Biotherapeutics


The ability of enzymes to remain active outside their source organism makes them an
ideal candidate for biotherapeutics. Some examples include recombinant enzymes, inprocess enzymes, and gene therapies intended to produce or replace enzymes to directly address a disease. The activity of these enzymes can be measured in many ways including absolute activity, specific activity, relative activity, or kinetic activity. The purpose of the work presented is to highlight various assay strategies to quantify enzymatic activity in ancillary material and drug products by using science-based andrisk-based strategies.