Development of thermostable lyophilized inactivated polio vaccine

Pharmaceutical Research

Volumn 31, Issue 10, 2014, Pages 2618-2629

  Kraan, Heleen ^a   Van Herpen, Paul ^a   Kersten, Gideon ^a,b   Amorij, Jean Pierre ^a  

^a Institute for Translational Vaccinology (Intravacc)   (Netherlands)

^b LEIDEN UNIVERSITY   (Netherlands)

Author keywords

design of experiments; formulation; inactivated polio vaccine; lyophilization

Indexed keywords

EXCIPIENT; POLIOMYELITIS VACCINE; ORAL POLIOMYELITIS VACCINE;

ARTICLE; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG ANTIGENICITY; DRUG FORMULATION; DRUG POTENCY; DRUG SAFETY; DRUG STABILITY; DRUG STORAGE; FREEZE DRYING; HIGH TEMPERATURE; THERMOSTABILITY; CHEMISTRY; IMMUNOLOGY; MEDICINAL CHEMISTRY; PARTICLE SIZE; PHARMACEUTICS; POLIOMYELITIS VIRUS; PROCEDURES; TEMPERATURE; TRANSITION TEMPERATURE;

CHEMISTRY, PHARMACEUTICAL; DRUG STABILITY; EXCIPIENTS; FREEZE DRYING; PARTICLE SIZE; POLIOVIRUS; POLIOVIRUS VACCINE, INACTIVATED; POLIOVIRUS VACCINE, ORAL; TECHNOLOGY, PHARMACEUTICAL; TEMPERATURE; TRANSITION TEMPERATURE;

EID: 84910012909     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-014-1359-6     Document Type: Article

References (43)

1. Davis R, Wright PF. Circulating vaccine derived poliovirus and the polio eradication endgame. The Pan African Med J. 2012;12:109.
2. Polio Eradication & Endgame Strategic Plan 2013-2018. http://www.polioeradication.org/Portals/0/Document/Resources/StrategyWork/PEESP-EN-A4.pdf: Global Polio Eradication Initiative; 2013 [cited 2013 1 August].
3. Ehrenfeld E, Modlin J, Chumakov K. Future of polio vaccines. Expert Rev Vaccines. 2009;8(7):899-905.
4. Bakker WA, Thomassen YE, van't Oever AG, Westdijk J, van Oijen MG, Sundermann LC, et al. Inactivated polio vaccine development for technology transfer using attenuated Sabin poliovirus strains to shift from Salk-IPV to Sabin-IPV. Vaccine. 2011;29(41):7188-96.
5. Westdijk J, Koedam P, Barro M, Steil BP, Collin N, Vedvick TS, et al. Antigen sparing with adjuvanted inactivated polio vaccine based on Sabin strains. Vaccine. 2013;31(9):1298-304.
6. Soonawala D, Verdijk P, Wijmenga-Monsuur AJ, Boog CJ, Koedam P, Visser LG, et al. Intradermal fractional booster dose of inactivated poliomyelitis vaccine with a jet injector in healthy adults. Vaccine. 2013.
7. Verdijk P, Rots NY, Bakker WA. Clinical development of a novel inactivated poliomyelitis vaccine based on attenuated Sabin poliovirus strains. Expert Rev Vaccines. 2011;10(5):635-44.
8. Amorij JP, Kersten GF, Saluja V, Tonnis WF, Hinrichs WL, Slutter B, et al. Towards tailored vaccine delivery: Needs, challenges and perspectives. J Control Release. 2012.
9. Clements CJ, Larsen G, Jodar L. Technologies that make administration of vaccines safer. Vaccine. 2004;22(15-16):2054-8.
10. Friede M, Aguado MT. Need for new vaccine formulations and potential of particulate antigen and DNA delivery systems. Adv Drug Deliv Rev. 2005;57(3):325-31.
11. Brandau DT, Jones LS, Wiethoff CM, Rexroad J, Middaugh CR. Thermal stability of vaccines. J Pharm Sci. 2003;92(2):218-31.
12. Chen D, Kristensen D. Opportunities and challenges of developing thermostable vaccines. Expert Rev Vaccines. 2009;8(5):547-57.
13. Amorij JP, Huckriede A, Wilschut J, Frijlink HW, Hinrichs WL. Development of stable influenza vaccine powder formulations: challenges and possibilities. Pharm Res. 2008;25(6):1256-73.
14. Bruce Aylward R, Sutter RW, Cochi SL, Thompson KM, Jafari H, Heymann D. Risk management in a polio-free world. Risk Anal. 2006;26(6):1441-8.
15. Thompson KM, Duintjer Tebbens RJ. The case for cooperation in managing and maintaining the end of poliomyelitis: stockpile needs and coordinated OPV cessation. Medscape J Med. 2008;10(8):190.
16. Tebbens RJ, Pallansch MA, Alexander JP, Thompson KM. Optimal vaccine stockpile design for an eradicated disease: application to polio. Vaccine. 2010;28(26):4312-27.
17. Jangle RD, Pisal SS. Vacuum foam drying: an alternative to lyophilization for biomolecule preservation. Indian J Pharm Sci. 2012;74(2):91-100.
18. Kim YC, Quan FS, Compans RW, Kang SM, Prausnitz MR. Stability kinetics of influenza vaccine coated onto microneedles during drying and storage. Pharm Res. 2011;28(1):135-44.
19. Maa YF, Zhao L, Payne LG, Chen D. Stabilization of alum-adjuvanted vaccine dry powder formulations: mechanism and application. J Pharm Sci. 2003;92(2):319-32.
20. Wang W. Lyophilization and development of solid protein pharmaceuticals. Int J Pharm. 2000;203:1-60.
21. Kraft LM, Pollard EC. Lyophilization of poliomyelitis virus; heat inactivation of dry MEFl virus. Proc Soc Exp Biol Med. 1954;86(2):306-9.
22. Nagel J, Hekker AC, Hofman B, Cohen H. Some experiments on freezedrying of inactivated poliomyelitis-vaccines. Arch Gesamte Virusforsch. 1963;12:718-20.
23. Portocala R, Samuel I, Popescu M. Effect of lyophilization on picornaviruses. (Brief report). Arch Gesamte Virusforsch. 1969;28(1):97-9.
24. Westdijk J, Brugmans D, Martin J, van't Oever A, Bakker WA, Levels L, et al. Characterization and standardization of Sabin based inactivated polio vaccine: proposal for a new antigen unit for inactivated polio vaccines. Vaccine. 2011;29(18):3390-7.
25. Bieganski RM, Fowler A, Morgan JR, Toner M. Stabilization of active recombinant retroviruses in an amorphous dry state with trehalose. Biotechnol Prog. 1998;14(4):615-20.
26. Mattern M, Winter G, Kohnert U, Lee G. Formulation of proteins in vacuum-dried glasses. II. Process and storage stability in sugar-free amino acid systems. Pharm Dev Technol. 1999;4(2):199-208.
27. Rossi S, Buera MP, Moreno S, Chirife J. Stabilization of the restriction enzyme EcoRI dried with trehalose and other selected glass-forming solutes. Biotechnol Prog. 1997;13(5):609-16.
28. Ten Have R, Thomassen YE, Hamzink MR, Bakker WA, Nijst OE, Kersten G, et al. Development of a fast ELISA for quantifying polio D-antigen in in-process samples. Biologicals. 2012;40(1):84-7.
29. Johnson RE, Kirchhoff CF, Gaud HT. Mannitol-sucrose mixtures-versatile formulations for protein lyophilization. J Pharm Sci. 2002;91(4):914-22.
30. Maa YF, Ameri M, Shu C, Payne LG, Chen D. Influenza vaccine powder formulation development: spray-freeze-drying and stability evaluation. J Pharm Sci. 2004;93(7):1912-23.
31. Maa YF, Ameri M, Shu C, Zuleger CL, Che J, Osorio JE, et al. Hepatitis-B surface antigen (HBsAg) powder formulation: process and stability assessment. Current Drug Deliv. 2007;4(1):57-67.
32. Zhai S, Hansen RK, Taylor R, Skepper JN, Sanches R, Slater NK. Effect of freezing rates and excipients on the infectivity of a live viral vaccine during lyophilization. Biotechnol Prog. 2004;20(4):1113-20.
33. Moynihan M, Petersen I. The durability of inactivated poliovirus vaccine: studies on the stability of potency in vivo and in vitro. J Biol Stand. 1982;10(3):261-8.
34. Pollard M. The inactivation of poliomyelitis virus by freeze-drying. Texas Rep Biol Med. 1951;9(4):749-54.
35. Mayeresse Y, Stephenne J. Inventors; GlaxoSmithKline Biologicals, assignee. Immunogenic composition 2004 13 May 2004.
36. Akers MJ, Milton N, Byrn SR, Nail SL. Glycine crystallization during freezing: the effects of salt form, pH, and ionic strength. Pharm Res. 1995;12(10):1457-61.
37. Berge TO, Jewett RL, Blair WO. Preservation of enteroviruses by freeze-drying. Appl Microbiol. 1971;22(5):850-3.
38. Leal ML, Lopes FJ, Carvalho MH, Moura HA, Soares SA. Study on thermostabilizers for trivalent oral poliomyelitis vaccine. Mem Inst Oswaldo Cruz. 1990;85(3):329-38.
39. Melnick JL. Thermostability of poliovirus and measles vaccines. Dev Biol Stand. 1996;87:155-60.
40. Ohtake S, Martin RA, Yee L, Chen D, Kristensen DD, Lechuga-Ballesteros D, et al. Heat-stable measles vaccine produced by spray drying. Vaccine. 2010;28(5):1275-84.
41. Cao W, Xie Y, Krishnan S, Lin H, Ricci M. Influence of process conditions on the crystallization and transition of metastable mannitol forms in protein formulations during lyophilization. Pharm Res. 2013;30(1):131-9.
42. Mehta M, Bhardwaj SP, Suryanarayanan R. Controlling the physical form of mannitol in freeze-dried systems. European Journal of Pharmaceutics and Biopharmaceutics: official Journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik eV. 2013.
43. Eriksson L, Johansson E, Kettaneh-Wold N, Wikström C, Wold S. Design of Experiments; Principles and Applications: Umetrics AB; 2008.