Preparation of highly concentrated influenza vaccine for use in novel delivery approaches

Journal of Pharmaceutical Sciences

Volumn 102, Issue 3, 2013, Pages 866-875

  Kommareddy, Sushma ^a   Bonificio, Amanda ^a   Gallorini, Simona ^b   Baudner, Barbara ^b   Singh, Manmohan ^a   O'Hagan, Derek ^a  

^a Vaccines Research   (United States)

^b NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

Author keywords

Formulation; Protein delivery; Protein formulation; Vaccine delivery; Vaccines

Indexed keywords

IMMUNOGLOBULIN G; INFLUENZA VACCINE; INFLUENZA VIRUS HEMAGGLUTININ; VIRUS ANTIBODY;

ANIMAL MODEL; ANTIBODY BLOOD LEVEL; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; CHEMICAL COMPOSITION; CONCENTRATION (PARAMETERS); DRUG DELIVERY SYSTEM; DRUG DETERMINATION; DRUG MANUFACTURE; DRUG SYNTHESIS; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; FILTRATION; GEL PERMEATION CHROMATOGRAPHY; IMMUNODIFFUSION; IMMUNOGENICITY; IMMUNOGLOBULIN BLOOD LEVEL; IN VIVO STUDY; INFLUENZA; INFLUENZA VACCINATION; MOUSE; NONHUMAN; POLYACRYLAMIDE GEL ELECTROPHORESIS; PROTEIN CONTENT; PROTEIN DETERMINATION; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; TANGENTIAL FLOW FILTRATION; VIRUS STRAIN;

EID: 84878154791     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23444     Document Type: Article

References (19)

1. Francis T, Magill TP. 1937. The antibody response of human subjects vaccinated with the virus of human influenza. J Exp Med 65(2):251-259.
2. World Health Organization. WHO Media Centere influenza fact sheet at: http://www.who.int/mediacentre/factsheets/fs211/en/.
3. Amorij JP, Hinrichs W, Frijlink HW, Wilschut JC, Huckriede A. 2010. Needle-free influenza vaccination. Lancet Infect Dis 10(10):699-711.
4. Dormitzer P, Tsai T, Del Giudice G. 2012. New technologies for influenza vaccines. Hum Vaccin Immunother 8(1):45-58.
5. Leroux-Roels I, Vets E, Freese R, Seiberling M, Weber F, Salamand C, Leroux-Roels G. 2008. Seasonal influenza vaccine delivered by intradermal microinjection: A randomised controlled safety and immunogenicity trial in adults. Vaccine 26(51):6614-6619.
6. Van Damme P, Oosterhuis-Kafeja F, Van der Wielen M, Almagor Y, Sharon O, Levin Y. 2009. Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Vaccine 27(3):454-459.
7. Ambrose CS, Luke C, Coelingh K. 2008. Current status of live attenuated influenza vaccine in the United States for seasonal and pandemic influenza. Influenza Other Respi Viruses 2(6):193-202.
8. Monto AS, Ohmit SE, Petrie JG, Johnson E, Truscon R, Teich E, Rotthoff J, Boulton M, Victor JC. 2009. Comparative efficacy of inactivated and live attenuated influenza vaccines. N Engl J Med 361(13):1260-1267.
9. Kommareddy S, Baudner BC, Oh S, Kwon SY, Singh M, O'Hagan DT. 2012. Dissolvable microneedle patches for the delivery of cell-culture-derived influenza vaccine antigens. J Pharm Sci 101(3):1021-1027.
10. Sullivan SP, Koutsonanos DG, Del Pilar Martin M, Lee JW, Zarnitsyn V, Choi SO, Murthy N, Compans RW, Skountzou I, Prausnitz MR. 2010. Dissolving polymer microneedle patches for influenza vaccination. Nat Med 16(8):915-920.
11. Amorij JP, Huckriede A, Wilschut J, Frijlink HW, Hinrichs WL. 2008. Development of stable influenza vaccine powder formulations: Challenges and possibilities. Pharm Res 25(6):1256-1273.
12. Saluja V, Amorij JP, Kapteyn JC, de Boer AH, Frijlink HW, Hinrichs WL. 2010. A comparison between spray drying and spray freeze drying to produce an influenza subunit vaccine powder for inhalation. J Control Release 144(2):127-133.
13. Raphael AP, Prow TW, Crichton ML, Chen X, Fernando GJ, Kendall MA. 2010. Targeted, needle-free vaccinations in skin using multilayered, densely-packed dissolving microprojection arrays. Small 6(16):1785-1793.
14. Zhu Q, Zarnitsyn VG, Ye L, Wen Z, Gao Y, Pan L, Skountzou I, Gill HS, Prausnitz MR, Yang C, Compans RW. 2009. Immunization by vaccine-coated microneedle arrays protects against lethal influenza virus challenge. Proc Natl Acad Sci USA 106(19):7968-7973.
15. Van Reis R, Goodrich EM, Yson CL, Frautschy LN, Dzengeleski S, Lutz H. 1997. Linear scale ultrafiltration. Biotechnol Bioeng 55(5):737-746.
16. Van Reis R, Zydney A. 2001. Membrane separations in biotechnology. Curr Opin Biotechnol 12(2):208-211.
17. Schild GC, Wood JM, Newman RW. 1975. A single-radial-immunodiffusion technique for the assay of influenza haemagglutinin antigen. Proposals for an assay method for the haemagglutinin content of influenza vaccines. Bull World Health Organ 52(2):223-231.
18. Kapteyn JC, Saidi MD, Dijkstra R, Kars C, Tjon JC, Weverling GJ, de Vocht ML, Kompier R, van Montfort BA, Guichoux JY, Goudsmit J, Lagerwerf FM. 2006. Haemagglutinin quantification and identification of influenza A&B strains propagated in PER. C6 cells: A novel RP-HPLC method. Vaccine 24(16):3137-3144.
19. Hegde NR, Kaveri SV, Bayry J. 2011. Recent advances in the administration of vaccines for infectious diseases: Microneedles as painless delivery devices for mass vaccination. Drug Discov Today 16(23-24):1061-1068.