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Stability evaluation of H3N2 influenza split vaccine in drying process for solidification

  • Sung-Jin Kim
  • Young-Guk Na
  • Hong-Ki Lee
  • Hye-Jin Lee
  • Miao Wang
  • Hyun Wook Huh
  • Han-Sol Lee
  • Jae-Young Lee
  • Cheong-Weon ChoEmail author
Original Article
  • 13 Downloads

Abstract

Purpose

Currently, most vaccines have been manufactured in liquid forms that are needed a cold-chain system. However, this system does not guarantee the stability of vaccines always and requires a high cost. Although solidification of vaccine can be alternative, vaccine stability is a problem. Recently, influenza vaccine delivery using microneedle formulation has been studied extensively. Moreover, the stability of the vaccine can be improved since the vaccine is solid form in the microneedle. Therefore, the aim of this study is to screen the suitable stabilizer in the drying process and to compare evaluation methods for H3N2 split vaccine stability.

Methods

Dried vaccine samples were evaluated by enzyme-linked immunosorbent assay (ELISA), sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) and circular dichroism (CD).

Results

Fructose provided stability to the vaccine during the drying process by ELISA (91.1 ± 8.9%) and SDS-PAGE (about 65%). Trehalose was rated as providing stability to the vaccine when evaluated with ELISA and SDS-PAGE but was not when evaluated with CD.

Conclusions

The stability of the vaccine should be finally determined by comprehensively evaluating the structure and antigenicity of various proteins.

Keywords

H3N2 influenza vaccine Drying process Stability Enzyme-linked immunosorbent assay Sodium dodecyl sulfate polyacrylamide gel electrophoresis Circular dichroism 

Notes

Acknowledgements

This work was supported by Industrial Strategic Technology Development Program (10067809, development of vaccine formulation and patient-convenient vaccine microneedle) funded by the Ministry of Trade, Industry & Energy (MOTIE, Korea) to Cheong-Weon Cho.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Statement of human and animal rights

This article does not contain any studies with human and animal subjects performed by any of the authors.

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Copyright information

© The Korean Society of Pharmaceutical Sciences and Technology 2019

Authors and Affiliations

  • Sung-Jin Kim
    • 1
  • Young-Guk Na
    • 1
  • Hong-Ki Lee
    • 1
  • Hye-Jin Lee
    • 1
  • Miao Wang
    • 1
  • Hyun Wook Huh
    • 1
  • Han-Sol Lee
    • 1
  • Jae-Young Lee
    • 1
  • Cheong-Weon Cho
    • 1
    Email author
  1. 1.College of Pharmacy and Institute of Drug Research and DevelopmentChungnam National UniversityDaejeonSouth Korea

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