title: EBF recommendation for stability testing of anti-drug antibodies; lessons learned from anti-vaccine antibody stability studies.
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.
authors: H Lundbeck A/S, Department of Bioanalysis, Drug Development ADME, H Lundbeck A/S, Ottiliavej 7-9, DK-2500 Valby, Denmark.
authors: Susanne
authors: S
authors: Pihl
authors: Lydia
authors: L
authors: Michaut
authors: Jenny
authors: J
authors: Hendriks
authors: Ralf
authors: R
authors: Loebbert
authors: Janka
authors: J
authors: Ryding
authors: Martin
authors: M
authors: Nemansky
authors: Laurent
authors: L
authors: Vermet
authors: Arjen
authors: A
authors: Companjen
mesh_terms: D000906:Antibodies / Q000097:blood* / Q000378:metabolism; D005060:Europe; D006801:Humans; D055550:Protein Stability; D011786:Quality Control; D013696:Temperature; D013997:Time Factors; D014612:Vaccines / Q000276:immunology*
chemical_list: D000906:Antibodies; D014612:Vaccines