Titer on chip: new analytical tool for influenza vaccine potency determination

• Published in: PloS one Vol. 9; no. 10; p. e109616
• Main Authors: Kuck, Laura R, Sorensen, Michelle, Matthews, Erin, Srivastava, Indresh, Cox, Manon M J, Rowlen, Kathy L
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 20.10.2014; Public Library of Science (PLoS)
• Subjects: Animals; Antigens; Assaying; Baculoviridae - genetics; Baculovirus; Biology and Life Sciences; Cell culture; Chromatography; Enzyme-linked immunosorbent assay; Enzymes; FDA approval; Hemagglutinin Glycoproteins, Influenza Virus - analysis; Hemagglutinin Glycoproteins, Influenza Virus - genetics; Hemagglutinin Glycoproteins, Influenza Virus - immunology; Hemagglutinins; Immunoassay; Immunoassay - instrumentation; Immunoassay - methods; Immunodiffusion; Immunoglobulins; Influenza; Influenza vaccines; Influenza Vaccines - immunology; Laboratories; Lectins; Mass spectrometry; Medicine and Health Sciences; Methods; Pandemics; Proteins; Recombinant Proteins - analysis; Recombinant Proteins - genetics; Recombinant Proteins - immunology; Regression analysis; Scientific imaging; Species Specificity; Vaccine Potency; Vaccines; Viruses; United States > US; Colorado; Connecticut
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0109616

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.