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

Bioanalysis. 2014 May;6(10):1409-13. doi: 10.4155/bio.14.95.

Abstract

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 to perform short-term stability testing of the positive control, but not to perform long-term stability testing of ADAs in nonclinical and clinical studies.

MeSH terms

  • Antibodies / blood*
  • Antibodies / metabolism
  • Europe
  • Humans
  • Protein Stability
  • Quality Control
  • Temperature
  • Time Factors
  • Vaccines / immunology*

Substances

  • Antibodies
  • Vaccines