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Background <p>As highlighted during the COVID-19 pandemic, vaccine stability and global accessibility pose critical challenges for effective immunization programs worldwide. Antigens are vulnerable to environmental factors that can compromise their structural integrity and efficacy. The conventional cold-chain infrastructure presents significant logistical, economic, and accessibility barriers, particularly in resource-limited settings. Developing thermostable and patient-centered vaccine platforms is a pharmaceutical innovation frontier with significant implications for global immunization coverage and infectious disease control.</p> Area covered <p>In this review, we cover innovative approaches to thermostable vaccine formulation, analyzing both antigen modification strategies and processing technologies that enhance product stability without compromising immunogenicity. We evaluate pharmaceutical processes, including conventional liquid formulations and advanced solid-state techniques, such as spray-drying, freeze-drying, spray-freeze-drying, and foam-drying. Nanoparticle (NP)-based delivery systems are assessed as versatile platforms for antigen presentation and stabilization. Lipid and fatty acid conjugation strategies are explored for their impact on thermal resistance and immunomodulation. Furthermore, patient-centered design principles that improve compliance and coverage through non-invasive administration routes are discussed.</p> Expert opinion <p>Recent advances in lipid conjugation techniques and protein-based NP systems demonstrate significant potential for enhancing vaccine thermostability while maintaining immunogenicity. The molecular engineering of antigens, combined with optimized solid-state processing methods, addresses critical stability challenges without compromising efficacy. Non-invasive delivery platforms that integrate these thermostable formulations show promising clinical results for improving patient acceptance and vaccination coverage. Future development should prioritize standardized stability parameters, scalable manufacturing processes, and regulatory considerations to translate these innovations into accessible vaccines that reduce cold-chain dependence and enhance global immunization efforts.</p>

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Advances in pharmaceutical formulation technologies for thermostable vaccine platforms considering patient-centered design

  • 期刊论文

  • 发表日期：

    2025年12月23日

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  • Euna Ko,
  • Jaehoon Hu,
  • Youngju Jeong,
  • Cheolho Oh,
  • Samad Muhammad Abdus,
  • Beom-Jin Lee,
  • Chulhun Park

摘要

Background

As highlighted during the COVID-19 pandemic, vaccine stability and global accessibility pose critical challenges for effective immunization programs worldwide. Antigens are vulnerable to environmental factors that can compromise their structural integrity and efficacy. The conventional cold-chain infrastructure presents significant logistical, economic, and accessibility barriers, particularly in resource-limited settings. Developing thermostable and patient-centered vaccine platforms is a pharmaceutical innovation frontier with significant implications for global immunization coverage and infectious disease control.

Area covered

In this review, we cover innovative approaches to thermostable vaccine formulation, analyzing both antigen modification strategies and processing technologies that enhance product stability without compromising immunogenicity. We evaluate pharmaceutical processes, including conventional liquid formulations and advanced solid-state techniques, such as spray-drying, freeze-drying, spray-freeze-drying, and foam-drying. Nanoparticle (NP)-based delivery systems are assessed as versatile platforms for antigen presentation and stabilization. Lipid and fatty acid conjugation strategies are explored for their impact on thermal resistance and immunomodulation. Furthermore, patient-centered design principles that improve compliance and coverage through non-invasive administration routes are discussed.

Expert opinion

Recent advances in lipid conjugation techniques and protein-based NP systems demonstrate significant potential for enhancing vaccine thermostability while maintaining immunogenicity. The molecular engineering of antigens, combined with optimized solid-state processing methods, addresses critical stability challenges without compromising efficacy. Non-invasive delivery platforms that integrate these thermostable formulations show promising clinical results for improving patient acceptance and vaccination coverage. Future development should prioritize standardized stability parameters, scalable manufacturing processes, and regulatory considerations to translate these innovations into accessible vaccines that reduce cold-chain dependence and enhance global immunization efforts.