DEVELOPMENT & QUALIFICATION OF BIOASSAYS FOR THE DETERMINATION OF THE BIOACTIVITY, PREDICTIVE PHARMACOKINETICS AND POTENTIAL IMMUNOGENICITY OF THERAPEUTIC ANTIBODIES

The critical quality attributes of a given biotherapeutic monoclonal antibody (mAb), its molecular characterization, functional assessment and effector function analysis should be defined and profiled in detail during the life cycle of a biotherapeutic drug. In the past, this product characterization was simple and standardized. In today’s complex world of biologics, success demands a more thoughtful approach and drug developers are investing in advanced analytics much earlier in the development process. Indeed, investing in selected sophisticated and state of the art analytics in early developmental phases of a therapeutic monoclonal antibody may mitigate risks by confirming that the drug …