This presentation provides a patient-centric approach to attribute criticality assessment using a case study in which oxidation is assessed to be a non-critical quality attribute for a monoclonal antibody. Brief overviews of oxidation as a quality attribute and the assays used to quantitate it are provided. Structure-function studies and prior knowledge related to oxidation are used to ascertain the potential impact of oxidation to potency, pharmacokinetics, safety, and immunogenicity. In order to demonstrate that oxidation levels are consistently below any threshold for concern, process and characterization data are reviewed. Finally, the link is drawn between analytical testing and patient impact, and an overview of control strategy is provided.
Learning Objectives:
Consider the different ways patients may be impacted by a given product quality attribute.
Identify characterization studies, prior knowledge, process data, and controls to support attribute criticality justification.
Understand the direct link between control strategy and quality attribute characterization/understanding.
.jpg "Benjamin K. Wheat, MS (he/him/his) photo")