School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, GA, 30332, USA.
Department of Microbiology and Immunology and Emory Vaccine Center, Emory University School of Medicine, Atlanta, GA, 30322, USA.
Drug Deliv Transl Res. 2021 Apr;11(2):692-701. doi: 10.1007/s13346-021-00927-4. Epub 2021 Feb 15.
Skin vaccination by microneedle (MN) patch simplifies the immunization process to increase access to vaccines for global health. Lyophilization has been widely used to stabilize vaccines and other biologics during storage, but is generally not compatible with the MN patch manufacturing processes. In this study, our goal was to develop a method to incorporate lyophilized inactivated H1N1 influenza vaccine into MN patches during manufacturing by suspending freeze-dried vaccine in anhydrous organic solvent during the casting process. Using a casting formulation containing chloroform and polyvinylpyrrolidone, lyophilized influenza vaccine maintained activity during manufacturing and subsequent storage for 3 months at 40 °C. Influenza vaccination using these MN patches generated strong immune responses in a murine model. This manufacturing process may enable vaccines and other biologics to be stabilized by lyophilization and administered via a MN patch.
皮肤疫苗接种通过微针（MN）贴片使免疫过程简化，以增加全球健康疫苗的可及性。冷冻干燥已广泛用于在储存过程中稳定疫苗和其他生物制剂，但通常与 MN 贴片制造工艺不兼容。在这项研究中，我们的目标是开发一种方法，即在制造过程中通过在铸造过程中将冻干的灭活 H1N1 流感疫苗悬浮在无水有机溶剂中来将其纳入 MN 贴片。使用含有氯仿和聚乙烯吡咯烷酮的铸造配方，冻干流感疫苗在制造过程中和随后在 40°C 下储存 3 个月期间保持活性。使用这些 MN 贴片进行流感疫苗接种在小鼠模型中产生了强烈的免疫反应。这种制造工艺可以通过冷冻干燥稳定疫苗和其他生物制剂，并通过 MN 贴片进行给药。
