Do you know the molar extinction coefficient of your (biologics) drug product? According to ICHQ6 the molar extinction coefficient needs to be experimentally determined for drug products. Here at ProJect Pharmaceutics, we are able to determine the extinction coefficient experimentally using an absolute gravimetric determination approach. Thereby we are able to consider not only the protein primary sequence but also glycosylation as part of the overall protein mass. This service is made available to all our clients from now on as part of a project.
