George R Gunn, Christopher Evans & Eric Yang
In drug development, particularly for biotherapeutics, analytical assessments of immunogenicity and biomarkers are two sides of the same coin. Both work closely with pharmacokinetic (PK) assessments to provide analytical evidence or correlations with drug efficacy and safety measures. While immunogenicity assessments are commonly qualitative or quasi-quantitative and biomarker analytic readouts are usually quantitative, both typically utilize similar analytical platforms. A significant focus on method quality and experimental validation is warranted to meet scientific and regulatory expectations due to the clinical importance and labeling implications of immunogenicity and biomarker assessments related to therapeutic efficacy and safety.