Qualification of a differential scanning calorimetry method for biophysical characterization of monoclonal antibodies and protein vaccine antigens

Abstract

Background: Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Methodology The focus of this study was the qualification of a differential scanning calorimetry method that is used to examine thermal stability and tertiary structure of protein vaccine antigens and monoclonal antibody products. The analytical parameter evaluated was precision, through assessment of the characteristics of repeatability and intermediate precision. Conclusion: The results demonstrated that the assay met the desired performance characteristics, and is suitable...