title: A semi-universal assay platform to quantitate vaccines with potential applications for biotherapeutics.
abstract: OBJECTIVE
  Biologics development often requires multiple immunoassays to evaluate both assay reagents and potential drug candidates resulting in extensive analytical development.
  
  
  METHODS
  We developed a semi-universal, 5-layer platform assay on Gyrolab using secondary antispecies or anti-isotype-specific capture and detection antibodies. We applied the assay to several multivalent vaccines.
  
  
  RESULTS
  Method performance exhibited a median accuracy of 110%, reproducibility of 9% CV and intermediate precision of 11% CV. System suitability criteria were met for 92.5% of the samples and only one out of 31 replicate samples exhibited a %CV greater than 20%.
  
  
  CONCLUSIONS
  The semi-universal Gyrolab assay allowed assay development without reagent labeling. The format could also be translated into a plate-based assay.
authors.affiliation: Merck & Co., Inc., 770 Sumneytown Pike, PO Box 4, West Point, PA 19486, USA.
authors.forename: Jeanette
authors.initials: J
authors.lastname: Roman
authors.affiliation: Merck & Co., Inc., 770 Sumneytown Pike, PO Box 4, West Point, PA 19486, USA.
authors.forename: Silikhone
authors.initials: S
authors.lastname: Bouaraphan
authors.affiliation: Merck & Co., Inc., 770 Sumneytown Pike, PO Box 4, West Point, PA 19486, USA.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Verch
mesh_terms: D000818:Animals; D000906:Antibodies / Q000032:analysis*; D001691:Biological Therapy / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay; D005456:Fluorescent Dyes / Q000737:chemistry; D007074:Immunoglobulin G / Q000032:analysis; D007132:Immunoglobulin Isotypes / Q000032:analysis; D051379:Mice; D015203:Reproducibility of Results; D014612:Vaccines / Q000032:analysis / Q000276:immunology*
chemical_list: D000906:Antibodies; D005456:Fluorescent Dyes; D007074:Immunoglobulin G; D007132:Immunoglobulin Isotypes; D014612:Vaccines
keywords: ELISA; Gyrolab; parallel line analysis; polysaccharides