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

Pihl, Susanne and Michaut, Lydia and Hendriks, Jenny and Loebbert, Ralph and Ryding, Janka and Nemansky, Martin and 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

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