title: Titer on chip: new analytical tool for influenza vaccine potency determination.
abstract: Titer on Chip (Flu-ToC) is a new technique for quantification of influenza hemagglutinin (HA) concentration. In order to evaluate the potential of this new technique, a comparison of Flu-ToC to more conventional methods was conducted using recombinant HA produced in a baculovirus expression system as a test case. Samples from current vaccine strains were collected from four different steps in the manufacturing process. A total of 19 samples were analysed by Flu-ToC (blinded), single radial immunodiffusion (SRID), an enzyme-linked immunosorbent assay (ELISA), and the purity adjusted bicinchoninic acid assay (paBCA). The results indicated reasonable linear correlation between Flu-ToC and SRID, ELISA, and paBCA, with regression slopes of log-log plots being 0.91, 1.03, and 0.91, respectively. The average ratio for HA content measured by Flu-ToC relative to SRID, ELISA, and paBCA was 83%, 147%, and 81%, respectively; indicating nearly equivalent potency determination for Flu-ToC relative to SRID and paBCA. These results, combined with demonstrated multiplexed analysis of all components within a quadrivalent formulation and robust response to HA strains over a wide time period, support the conclusion that Flu-ToC can be used as a reliable and time-saving alternative potency assay for influenza vaccines.
authors.affiliation: InDevR Inc., Boulder, Colorado, United States of America.
authors.forename: Laura R
authors.initials: LR
authors.lastname: Kuck
authors.affiliation: Protein Sciences Corporation, Meriden, Connecticut, United States of America.
authors.forename: Michelle
authors.initials: M
authors.lastname: Sorensen
authors.affiliation: Protein Sciences Corporation, Meriden, Connecticut, United States of America.
authors.forename: Erin
authors.initials: E
authors.lastname: Matthews
authors.affiliation: Protein Sciences Corporation, Meriden, Connecticut, United States of America.
authors.forename: Indresh
authors.initials: I
authors.lastname: Srivastava
authors.affiliation: Protein Sciences Corporation, Meriden, Connecticut, United States of America.
authors.forename: Manon M J
authors.initials: MM
authors.lastname: Cox
authors.affiliation: InDevR Inc., Boulder, Colorado, United States of America.
authors.forename: Kathy L
authors.initials: KL
authors.lastname: Rowlen
mesh_terms: D000818:Animals; D016367:Baculoviridae / Q000235:genetics; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000032:analysis* / Q000235:genetics / Q000276:immunology; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods*; D007252:Influenza Vaccines / Q000276:immunology*; D011994:Recombinant Proteins / Q000032:analysis / Q000235:genetics / Q000276:immunology; D013045:Species Specificity; D064166:Vaccine Potency
chemical_list: D019267:Hemagglutinin Glycoproteins, Influenza Virus; D007252:Influenza Vaccines; D011994:Recombinant Proteins