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KMID : 1146920200500010107
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Journal of Pharmaceutical Investigation
2020 Volume.50 No. 1 p.107 ~ p.113
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Stability evaluation of H3N2 influenza split vaccine in drying process for solidification
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Kim Sung-Jin
Na Young-Guk
Lee Hong-Ki
Lee Hye-Jin
Wang Miao
Huh Hyun-Wook
Lee Han-Sol
Lee Jae-Young
Cho Cheong-Weon
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Abstract
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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.
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KEYWORD
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H3N2 influenza vaccine, Drying process, Stability, Enzyme-linked immunosorbent assay, Sodium dodecyl sulfate polyacrylamide gel electrophoresis, Circular dichroism
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