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

• Published in: Journal of pharmaceutical investigation Vol. 50; no. 1; pp. 107 - 113
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Singapore Springer Singapore 2020; 한국약제학회
• Subjects: Biomedical and Life Sciences; Biomedicine; Original Article; 약학; H3N2 influenza vaccine; Stability; Drying process; Sodium dodecyl sulfate polyacrylamide gel electrophoresis; Enzyme-linked immunosorbent assay; Circular dichroism
• ISSN: 2093-5552; 2093-6214
• DOI: 10.1007/s40005-019-00437-z

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.