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Updated: Apr 27, 2026
Laboratory Scale Production and Purification of a Therapeutic Antibody
Published on: January 24, 2017
Stability of anti-immunotherapeutic antibodies in frozen human serum samples
Lydia Michaut1, Nathalie Laurent, Kerstin Kentsch
1Novartis Institutes for Biomedical Research, DMPK-Biologics, Bioanalytics, Klybeckstrasse 141, CH-4057 Basel, Switzerland.
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.
