STABILITY TESTING OF ANTI-VACCINE ANTIBODIES IN HUMAN SERUM

Background: To generate exhaustive data on the stability of human anti-vaccine or anti-drug antibodies, we designed a GLP study using anti-vaccine antibodies (AVA) samples collected from over 100 different subjects. Samples were selected from various time points after vaccination to cover the heterogeneity of the polyclonal human immune response. Samples were analyzed shortly after serum collection using specific ELISAs and re-analyzed after long-term storage or multiple cycles of freeze-thaw (FT). The general acceptance criteria for incurred sample reanalysis (ISR) for ligand binding assays (LBA) were applied, as well as some alternative stricter acceptance criteria promoted by various white papers. Results: Anti-vaccine antibodies are stable in undiluted serum for at least three cycles of freeze-thaw and at least 3.5 years storage at a nominal temperature of -80°C. Conclusion: The nature of the humoral immune response allows extending the conclusion of this study to all anti-vaccine and anti-drug antibodies, making it unnecessary to test long-term stability for each new biological therapeutics or vaccine program