title: Effects of blood processing and sample storage on the stability of biotherapeutics and anti-drug antibodies.
abstract: BACKGROUND
  Pre-analytical factors such as sample processing, handling or storage could affect the stability of biotherapeutics and anti-drug antibodies in clinical samples, potentially impacting the pharmacokinetic and immunogenicity assessments.
  
  
  METHODS
  We used sarilumab, a fully human IgG1 monoclonal antibody, and evaluated the stability of sarilumab (both functional and bound forms) and anti-sarilumab antibodies in blood samples during serum collection and the impact of various processing conditions on the analyte stability in serum for long-term storage. We also assessed the incurred sample stability of these analytes in samples from clinical studies.
  
  
  CONCLUSIONS
  Assessment of analyte stability can provide relevant information about sample stability under different pre-analytical conditions and improve the confidence in the validity of bioanalytical data generated.
authors.affiliation: Department of Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Andisik
authors.affiliation: Department of Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: DeStefano
authors.affiliation: Department of Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
authors.forename: Colin
authors.initials: C
authors.lastname: Stefan
authors.affiliation: Department of Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
authors.forename: Meghna
authors.initials: M
authors.lastname: Gathani
authors.affiliation: Department of Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Laurino
authors.affiliation: Department of Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
authors.forename: Vicky Ch
authors.initials: VCh
authors.lastname: Lai
authors.affiliation: Department of Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
authors.forename: Manoj
authors.initials: M
authors.lastname: Rajadhyaksha
authors.affiliation: Department of Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
authors.forename: Albert
authors.initials: A
authors.lastname: Torri
authors.affiliation: Department of Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
authors.forename: Weiping
authors.initials: W
authors.lastname: Shao
mesh_terms: D000818:Animals; D000906:Antibodies / Q000276:immunology*; D061067:Antibodies, Monoclonal, Humanized / Q000097:blood* / Q000276:immunology* / Q000378:metabolism; D001793:Blood Preservation / Q000379:methods; D001800:Blood Specimen Collection / Q000379:methods; D004355:Drug Stability; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods; D008163:Luminescent Measurements / Q000379:methods; D008297:Male; D055550:Protein Stability; D044967:Serum / Q000276:immunology / Q000378:metabolism
chemical_list: D000906:Antibodies; D061067:Antibodies, Monoclonal, Humanized; C000592401:sarilumab