Improved stability of recombinant hemagglutinin using a formulation containing sodium thioglycolate

Vaccine

Volumn 33, Issue 44, 2015, Pages 6011-6016

  Rhodes, David G ^a   Holtz, Kathy ^a   Robinson, Pam ^a   Wang, Keyang ^a   McPherson, Clifton E ^a   Cox, Manon M J ^a   Srivastava, Indresh K ^a  

^a Protein Sciences Corp   (United States)

Author keywords

Influenza vaccine; RHA; SRID; Stability; STG

Indexed keywords

CITRATE SODIUM; CITRIC ACID; DISULFIDE; INFLUENZA VACCINE; POLYMER; RECOMBINANT INFLUENZA HEMAGGLUTININ; THIOGLYCOLIC ACID DERIVATIVE; UNCLASSIFIED DRUG; 2-MERCAPTOACETATE; HEMAGGLUTININ; RECOMBINANT PROTEIN; VACCINE; VIRUS ANTIBODY;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CONTROLLED STUDY; CROSS LINKING; DRUG FORMULATION; DRUG MECHANISM; DRUG POTENCY; DRUG STABILITY; DRUG STRUCTURE; IMMUNIZATION; IMMUNODIFFUSION; IMMUNOGENICITY; INFLUENZA VIRUS; LIGHT SCATTERING; LIQUID; MOUSE; NONHUMAN; PARTICLE SIZE; POLYACRYLAMIDE GEL ELECTROPHORESIS; PRIORITY JOURNAL; PROTEIN FUNCTION; SHELF LIFE; VIRUS STRAIN; ANIMAL; BAGG ALBINO MOUSE; BLOOD; CHEMISTRY; GENETICS; IMMUNOLOGY; PHOTON CORRELATION SPECTROSCOPY;

ANIMALS; ANTIBODIES, VIRAL; DYNAMIC LIGHT SCATTERING; ELECTROPHORESIS, POLYACRYLAMIDE GEL; HEMAGGLUTININS; IMMUNODIFFUSION; INFLUENZA VACCINES; MICE, INBRED BALB C; RECOMBINANT PROTEINS; THIOGLYCOLATES; VACCINE POTENCY;

EID: 84947419624     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.09.029     Document Type: Article

References (25)

1. Cox M.M., Hashimoto Y. A fast track influenza virus vaccine produced in insect cells. J Invertebr Pathol 2011, 107(Suppl):S31-S41.
2. Cox M.M. Progress on baculovirus-derived influenza vaccines. Curr Opin Mol Ther 2008, 10:56-61.
3. Baxter R., Patriarca P.A., Ensor K., Izikson R., Goldenthal K.L., Cox M.M. Evaluation of the safety, reactogenicity, and immunogenicity of FluBlok(R) trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to health adults 50-64 years of age. Vaccine 2011, 29:2272-2278.
4. Palese P. Making better influenza virus vaccines. Emerg Infect Dis 2006, 12:61-65.
5. WHO: Recommendations for the production and control of influenza vaccine (inactivated). [http://www.who.int/biologicals/vaccines/influenza/en/].
6. Kamionka M. Engineering of therapeutic proteins production in Escherichia coli. Curr Pharm Biotechnol 2011, 12:268-274.
7. Swarbrick J. Ch. 114. Excipients: parenteral dosage forms and their role. Encyclopedia of pharmaceutical technology 2006, 3rd ed.
8. Lee Lih-Huei, Wu Po-Yi, Sun Erkuan, Richard King Chi-Hsin Canadian patent #CA2693041 Antimicrobial Parenteral Formulation 2009.
9. Xu S., Zhou J., Liu K., Liu Q., Xue C., Li X., et al. Mutations of two transmembrane cysteines of hemagglutinin (HA) from influenza A H3N2 virus affect HA thermal stability and fusion activity. Virus Genes 2013, 47:20-26.
10. Zhou J., Xu S., Ma J., Lei W., Liu K., Liu Q., et al. Recombinant influenza A H3 N2 viruses with mutations of HA transmembrane cysteines exhibited altered virological characteristics. Virus Genes 2014, 48:273-282.
11. Xu S., Zhou J., Liu Q., Liu K., Xue C., Li X., et al. Evidences for the existence of intermolecular disulfide-bonded oligomers in the H3 hemagglutinins expressed in insect cells. Virus Genes 2014, 48:304-311.
12. Liu Q.L., Liu K., Xue C.Y., Zhou J., Li X., Luo D., et al. Recombinant influenza H1, H5, and H9 hemagglutinins containing replaced H3 hemagglutinin transmembrane domain showed enhanced heterosubtypic protection in mice. Vaccine 2014, 32:3041-3049.
13. Hickey J.M., Holtz K.M., Manikwar P., Joshi S.B., Mcpherson C.E., Buckland B., et al. Mechanism of a decrease in potency for the recombinant influenza A virus hemagglutinin H3 antigen during storage. J Pharm Sci 2014, 103:821-827.
14. Holtz K., Robinson P., Matthews E., Hashimoto Y., McPherson C., Khramtsov N., et al. Modifications of cysteine residues in the 3 transmembrane and cytoplasmic domains of a recombinant hemagglutinin protein prevents cross-linked multimer formation and potency loss. BMC Biotechnol 2014, 14:111.
15. Jenkins C. A clinical study of 'sus-phrine,' an aqueous epinephrine suspension for sustained action. JAMA 1953, 45:120-122.
16. Schwartz A., Lipton J., Warburton D., Johnson L., Twarog F. Management of acute asthma in childhood - a randomized evaluation of β-adrenergic agents. Am J Dis Child 1980, 134:474-478.
17. Ben Zvi Z., Lam C., Hoffman J., Teets-Grimm K., Kattan M. An evaluation of the initial treatment of acute asthma. Pediatrics 1982, 70:348-353.
18. Feshchenko E., Joseph A., Rininger J.A., McPherson C., Rhodes D.G., Cox M. Biochemical, biophysical, and immunological characterization of A/California/07/2009 (H1N1) rHA and comparability comparison to other rHA PROTEINS. BMC Biotechnol 2012, 12:77.
19. Williams M.S. Single-radial-immuno-diffusion as an in vitro potency assay for human inactivated viral vaccines. Vet Microbiol 1993, 37:253-262.
20. Williams M.S., Mayner R.E., Daniel N.J., Phelan M.A., Rastogi S.C., Bozeman F.M., et al. New developments in the measurement of the hemagglutinin content of influenza virus vaccines by single-radial-immunodiffusion. J Biol Stand 1980, 8:289-296.
21. Bottcher C., Ludwig K., Herrmann A., van Heel M., Stark H. Structure of influenza haemagglutinin at neutral and at fusogenic pH by electron cryo-microscopy. FEBS Lett 1999, 463:255-259.
22. Ruigrok R.W.H., Wrigley N.G., Calder L.J., Cusack S., Wharton S.A., Brown E.B., et al. Electron microscopy of the low pH structure of influenza virus haemagglutinin. EMBO J 1986, 5:41-49.
23. Carpenter J.F., Randolph T.W., Jiskoot W., Crommelin D.J., Middaugh C.R., Winter G., et al. Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J Pharm Sci 2009, 98:1201-1205.
24. Fradkin A.H., Carpenter J.F., Randolph T.W. Immunogenicity of aggregates of recombinant human growth hormone in mouse models. J Pharm Sci 2009, 98:3247-3264.
25. Barnard J.G., Babcock K., Carpenter J.F. Characterization and quantitation of aggregates and particles in interferon-β products: potential links between product quality attributes and immunogenicity. J Pharm Sci 2013, 102:915-928.