BACKGROUND: To generate exhaustive data on the stability of human anti-immunotherapeutic antibodies. MATERIALS & METHODS: Samples collected from over 100 different subjects at various timepoints were analyzed shortly after serum collection using specific ELISAs and re-analyzed after long-term storage or multiple cycles of freeze-thaw. The general acceptance criteria for incurred sample reanalysis for ligand-binding assays were applied, as well as alternative stricter acceptance criteria promoted by various white papers. RESULTS: Anti-immunotherapeutic antibodies are stable in undiluted serum samples stored at -80°C for at least 3.5 years and 3-12 freeze-thaw cycles. CONCLUSION: Samples were selected to cover the heterogeneity of the polyclonal human immune response, therefore this stability data can be extended to all anti-vaccine and anti-drug antibodies.
BACKGROUND: To generate exhaustive data on the stability of human anti-immunotherapeutic antibodies. MATERIALS & METHODS: Samples collected from over 100 different subjects at various timepoints were analyzed shortly after serum collection using specific ELISAs and re-analyzed after long-term storage or multiple cycles of freeze-thaw. The general acceptance criteria for incurred sample reanalysis for ligand-binding assays were applied, as well as alternative stricter acceptance criteria promoted by various white papers. RESULTS: Anti-immunotherapeutic antibodies are stable in undiluted serum samples stored at -80°C for at least 3.5 years and 3-12 freeze-thaw cycles. CONCLUSION: Samples were selected to cover the heterogeneity of the polyclonal human immune response, therefore this stability data can be extended to all anti-vaccine and anti-drug antibodies.
Authors: Richard B Kennedy; Inna G Ovsyannikova; Antonia Thomas; Beth R Larrabee; Steven Rubin; Gregory A Poland Journal: Vaccine Date: 2019-02-20 Impact factor: 3.641
Authors: Elizabeth A Harrington; Jennifer L Sloan; Irini Manoli; Randy J Chandler; Mark Schneider; Peter J McGuire; Roberto Calcedo; James M Wilson; Charles P Venditti Journal: Hum Gene Ther Date: 2016-03-22 Impact factor: 5.695