Development of Thermostable Lyophilized Inactivated Polio Vaccine

The aim of current study was to develop a dried inactivated polio vaccine (IPV) formulation with minimal loss during the drying process and improved stability when compared with the conventional liquid IPV. Extensive excipient screening was combined with the use of a Design of Experiment (DoE) approach in order to achieve optimal results with high probability. Although it was shown earlier that the lyophilization of a trivalent IPV while conserving its antigenicity is challenging, we were able to develop a formulation that showed minimal loss of potency during drying and subsequent storage at higher temperatures. This study showed the potential of a highly stable and safe lyophilized polio vaccine, which might be used in developing countries without the need of a cold-chain.

• Publication year

  2014

• Venue

  Pharmaceutical Research

• Publication date

  2014-04-24

• Fields of study

  Medicine

• Identifiers
  DOI 10.1007/s11095-014-1359-6PMID 24760448PMCID 4197379
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

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  2012cited by this paper
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  2012cited by this paper
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  2012cited by this paper
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  2011cited by this paper
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  2010cited by this paper
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  2010cited by this paper
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  2010cited by this paper
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  2009cited by this paper
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  2009cited by this paper
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  2008cited by this paper
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  2008cited by this paper
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  2007cited by this paper
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  2006cited by this paper
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  2005cited by this paper
• Some experiments on freezedrying of inactivated poliomyelitis-vaccines

  2005cited by this paper
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  2005cited by this paper
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  2004cited by this paper
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  2004cited by this paper
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  2004cited by this paper
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  2002cited by this paper
• Design of Experiments, Principles and Applications, L. Eriksson, E. Johansson, N. Kettaneh‐ Wold, C. Wikström and S. Wold, Umetrics AB, Umeå Learnways AB, Stockholm, 2000, ISBN 91‐973730‐0‐1, xii + 329 pp.

  2001cited by this paper
• Lyophilization and development of solid protein pharmaceuticals.

  2000cited by this paper
• Formulation of proteins in vacuum-dried glasses. II. Process and storage stability in sugar-free amino acid systems.

  1999cited by this paper
• Stabilization of Active Recombinant Retroviruses in an Amorphous Dry State with Trehalose

  1998cited by this paper
• Stabilization of the restriction enzyme EcoRI dried with trehalose and other selected glass-forming solutes.

  1997cited by this paper
• Stabilization of the Restriction Enzyme EcoRI Dried with Trehalose and Other Selected Glass‐Forming Solutes

  1997cited by this paper
• Thermostability of poliovirus and measles vaccines.

  1996influential reference
• Glycine Crystallization During Freezing: The Effects of Salt Form, pH, and Ionic Strength

  1995cited by this paper
• Study on thermostabilizers for trivalent oral poliomyelitis vaccine.

  1990cited by this paper
• The durability of inactivated poliovirus vaccine: studies on the stability of potency in vivo and in vitro.

  1982cited by this paper
• Preservation of enteroviruses by freeze-drying.

  1971cited by this paper
• Effect of lyophilization on picornaviruses. (Brief report).

  1969cited by this paper
• Lyophilization of Poliomyelitis Virus. Heat Inactivation of Dry MEF1 Virus.∗

  1954cited by this paper
• The inactivation of poliomyelitis virus by freeze-drying.

  1951cited by this paper

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  2023cites this paper
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  2023cites this paper
• Lyophilized vaccine development

  2022cites this paper
• Current and next-generation formulation strategies for inactivated polio vaccines to lower costs, increase coverage, and facilitate polio eradication

  2022influential citation
• Freeze-drying: A Flourishing Strategy to Fabricate Stable Pharmaceutical and Biological Products.

  2022cites this paper
• Promising opportunities to improve polio vaccines

  2022cites this paper
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  2021cites this paper
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  2020cites this paper
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  2020influential citation
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  2020cites this paper
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  2019cites this paper
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  2019cites this paper
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  2019cites this paper
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  2018cites this paper
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  2018cites this paper
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  2018cites this paper
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  2018cites this paper
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  2018cites this paper
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  2018cites this paper
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  2018influential citation
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  2018cites this paper
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