title: Stability of anti-immunotherapeutic antibodies in frozen human serum samples.
abstract: BACKGROUND
  To generate exhaustive data on the stability of human anti-immunotherapeutic antibodies.
  
  
  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.
  
  
  CONCLUSIONS
  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: Novartis Institutes for Biomedical Research, DMPK-Biologics, Bioanalytics, Klybeckstrasse 141, CH-4057 Basel, Switzerland.
authors: Lydia
authors: L
authors: Michaut
authors: Nathalie
authors: N
authors: Laurent
authors: Kerstin
authors: K
authors: Kentsch
authors: Sebastian
authors: S
authors: Spindeldreher
authors: Fabienne
authors: F
authors: Deckert-Salva
mesh_terms: D000906:Antibodies / Q000097:blood* / Q000276:immunology / Q000378:metabolism; D004797:Enzyme-Linked Immunosorbent Assay; D005615:Freezing; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood / Q000276:immunology / Q000378:metabolism; D007075:Immunoglobulin M / Q000097:blood / Q000276:immunology; D020416:Outsourced Services; D055550:Protein Stability; D013696:Temperature; D013997:Time Factors; D014611:Vaccination; D014612:Vaccines / Q000276:immunology
chemical_list: D000906:Antibodies; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D014612:Vaccines