EBF recommendation for stability testing of anti-drug antibodies; lessons learned from anti-vaccine antibody stability studies

Long- and short-term stability testing of the analyte is one of the key parameters in bioanalytical method validation in support of pharmacokinetics. However, for immunogenicity testing, the scientific rationale for long- and short-term stability testing on quality control samples most often spiked with polyclonal antibody raised in a different species should be questioned. Therefore, the European Bioanalysis Forum (EBF) formed a Topic Team to discuss the scientific rationale for stability testing of anti-drug antibodies (ADAs). A review of EBF member companies’ experience on ADA stability and on anti-vaccine antibodies from vaccine projects was the basis of this discussion. EBF recommends...