Pihl, Susanne, Michaut, Lydia, Hendriks, Jenny, Loebbert, Ralph, Ryding, Janka, Nemansky, Martin, Vermet, Laurent and Companjen, Arjen (2014) EBF Recommendation for stability testing of anti-drug antibodies; lessons learned from anti-vaccine antibody stability studies. Bioanalysis, 6 (10). pp. 1409-1413. ISSN 1757-6180

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 (QC) 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 (TT) to discuss the scientific rationale for stability testing of anti-drug antibodies (ADA). A review of EBF member companies’ experience on ADA stability and data from vaccine projects was the basis of this discussion. EBF recommends to perform short-term stability testing but not to perform long-term stability testing of ADAs in non-clinical and clinical studies.

Item Type:	Article
Keywords:	ADAs (Anti-drug antibodies); Stability testing; Long-term stability: AVAs /Anti-vaccine antibodies)
Date Deposited:	13 Oct 2015 13:13
Last Modified:	13 Oct 2015 13:13
URI:	https://oak.novartis.com/id/eprint/11011