Stabilization of Live Attenuated Influenza Vaccines by Freeze Drying, Spray Drying, and Foam Drying

详细信息    查看全文

• 作者：Phillip M. Lovalenti ; Jeff Anderl ; Luisa Yee ; Van Nguyen…
• 刊名：Pharmaceutical Research
• 出版年：2016
• 出版时间：May 2016
• 年：2016
• 卷：33
• 期：5
• 页码：1144-1160
• 全文大小：814 KB
• 参考文献：1.Cumulative number of confirmed human cases of avian influenza A/(H5N1) reported to WHO. World Health Organization (WHO) website. Available at: http://​www.​who.​int/​csr/​disease/​avian_​influenza/​country/​cases_​table_​2009_​11_​27/​en/​index.​html . Accessed December 9, 2009.
  2.Homeland Security Council. National Strategy for Pandemic Influenza: Implementation Plan. Homeland Security Council: Washington, DC; 2006. Available at: http://​georgewbush-whitehouse.​archives.​gov/​homeland/​nspi_​implementation.​pdf .
  3.Ohtake S, Lechuga-Ballesteros D, Truong-Le V, Patzer EJ. Strategies for heat-stable vaccines. In: Wen EP, Ellis R, Pujar NS, editors. Vaccine Development and Manufacturing. Hoboken: Wiley; 2015.
  4.The Congress of the United States Congressional Budget Office (CBO). Stockpiling vaccine. In: Orszag PR, ed. US Policy Regarding Pandemic-Influenza Vaccines. Washington, DC: CBO; 2008:25–28. Available at: http://​www.​cbo.​gov/​ftpdocs/​95xx/​doc9573/​Chapter4.​8.​1.​shtml .
  5.The Department of Health and Human Services (DHHS). Pandemic Influenza Preparedness Spending. Washington, DC: HHS; 2009. Available at: http://​www.​hhs.​gov/​aspr/​barda/​mcm/​panflu/​hhspanflu-spending-0901.​pdf .
  6.Dormitzer PR, Mandl CW, Rappuoli R. Replicating Vaccines: A New Generation. Basel: Springer; 2011.CrossRef
  7.Kumru OS, Joshi SB, Smith DE, Middaugh CR, Prusik T, Volkin DB. Vaccine instability in the cold chain: Mechanisms, analysis and formulation strategies. Biologicals. 2014;42:237–59.CrossRef PubMed
  8.Cicerone MT, Tellington A, Trost L, Sokolov A. Plasticized Hydrophilic Glasses for Improved Stabilization of Biological Agents. US Patent. 2006;7:101,693.
  9.Cicerone MT, Tellington A, Trost L, Sokolov A. Substantially improved stability of biological agents in dried form. BioProc Int. 2003;1:36–47.
  10.Cicerone MT, Soles CL, Chowdhuri Z, Pikal MJ, Chang L. Fast dynamics as a diagnostic for excipients in preservation of dried proteins. Am Pharm Rev. 2005;8(6):22–7.
  11.Abdul-Fattah AM, Truong-Le V, Yee L, Pan E, Ao Y, Kalonia DS, et al. Drying-induced variations in physico-chemical properties of amorphous pharmaceuticals and their impact on Stability II: stability of a vaccine. Pharm Res. 2007;24(4):715–27.CrossRef PubMed
  12.Ohtake S, Martin RA, Yee L, Chen D, Kristensen DD, Lechuga-Ballesteros D, et al. Heat-Stable Measles Vaccine Produced By Spray Drying. Vaccine. 2009;28:1275–84.CrossRef PubMed
  13.Truong-Le V, Ohtake S, Lechuga-Ballesteros D, Martin RA, Pham BV, Saxena A, Chiueh G. Formulation for Room Temperature Stabilization of a Live Attenuated Bacterial Vaccine. Patent WO 2011/032108. 2011.
  14.Ohtake S, Truong-Le V, Yee L, Martin RA, Lechuga-Ballesteros D. Methods and Compositions for Stabilization of a Virus Vaccine. US Patent US 2011/0243988. 2011.
  15.Truong-Le V, Yee L, Lechuga-Ballesteros D, Ohtake S. Formulations for preservation of rotavirus. US Patent US. 2012;8241886.
  16.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.CrossRef PubMed
  17.Truong-Le V, Abdul-Fattah AM. The impact of formulation and drying processes on the characteristics and performance of biopharmaceutical powders. In: Jameel F, Hershenson S, editors. Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals. Hoboken: Wiley; 2010.
  18.Truong-Le V, Ohtake S, Martin RA, Pham BV, Yee L. Sonic Low Pressure Spray Drying. US Patent. 2014;8:673,357.
  19.Payment P, Trudel M. Methods and Techniques in Virology. New York: Marcel Dekker; 1993.
  20.Yannarell DA, Goldberg KM, Hjorth RN. Stabilizing cold-adapted influenza virus vaccine under various storage conditions. J Virol Methods. 2002;102:15–25.CrossRef PubMed
  21.Abdul-Fattah AM, Truong-Le V, Yee L, Nguyen L, Kalonia DS, Cicerone MT, et al. Drying-induced variations in physico-chemical properties of amorphous pharmaceuticals and their impact on Stability I: stability of a monoclonal antibody. J Pharm Sci. 2007;96:1983–2008.CrossRef PubMed
  22.Abdul-Fattah AM, Kalonia DS, Pikal MJ. The challenge of drying method selection for protein pharmaceuticals: product quality implications. J Pharm Sci. 2007;96(8):1886–916.CrossRef PubMed
  23.Amorij J-P, Huckriede A, Wilschut J, Frijlink HW, Hinrichs WLJ. Development of Stable Influenza Vaccine Powder Formulations: Challenges and Possibilities. Pharm Res. 2008;25(6):1256–73.CrossRef PubMed PubMedCentral
  
• 作者单位：Phillip M. Lovalenti (1)
  Jeff Anderl (1)
  Luisa Yee (1)
  Van Nguyen (1)
  Behnaz Ghavami (1)
  Satoshi Ohtake (1)
  Atul Saxena (1)
  Thomas Voss (2)
  Vu Truong-Le (1)
  
  1. Aridis Pharmaceuticals, 5941 Optical Court, San Jose, California, 95138, USA
  2. SRI International, Harrisonburg, Virginia, USA
  
• 刊物类别：Biomedical and Life Sciences
• 刊物主题：Biomedicine
  Pharmacology and Toxicology
  Pharmacy
  Biochemistry
  Medical Law
  Biomedical Engineering
  
• 出版者：Springer Netherlands
• ISSN：1573-904X

文摘

Purpose The goal of this research is to develop stable formulations for live attenuated influenza vaccines (LAIV) by employing the drying methods freeze drying, spray drying, and foam drying.