Bioanalytics – Chemical
2019 PharmSci 360
Bioanalytical method development and validation is critical for limiting immunologically related adverse clinical events related to therapeutic protein products. Anti-drug antibodies (ADA) can develop in patients during therapeutic protein treatment, and thus their potential formation must be assessed early in clinical trials. Detection and analysis of ADA is an important tool for understanding these potentially dangerous immune responses. The methods for addressing ADA formation and immunogenicity in trial patients, how ADA can be detected, and challenges for method development and validation will be discussed.