Pahal Suman, Huang Feifei, Singh Parbeen, Sharma Nidhi, Pham Hoang-Phuc, Tran Thi Bao Tram, Sakhrie Aseno, Akbaba Hasan, Duc Nguyen Thanh
Institute of Materials Science, Polymer Program, University of Connecticut, Storrs, CT, 06269, USA.
Department of Biomedical Engineering, University of Connecticut, Storrs, CT, 06269, USA.
Drug Deliv Transl Res. 2025 Apr 16. doi: 10.1007/s13346-025-01854-4.
Micron-scale needles, so-called microneedles (MNs) offer a minimally invasive, nearly painless, and user-friendly method for effective intradermal immunization. Maintaining the stability of antigens and therapeutics is the primary challenge in producing vaccine or drug-loaded MNs. The manufacturing of MNs patches involves processes at ambient or higher temperatures and various physio-mechanical stresses that can impact the therapeutic efficacy of sensitive biologics or vaccines. Therefore, it is crucial to develop techniques that safeguard vaccines and other biological payloads within MNs. Despite growing research interest in deploying MNs as an efficient tool for delivering vaccines, there is no comprehensive review that integrates the strategies and efforts to preserve the thermostability of vaccine payloads to ensure compatibility with MNs fabrication. The discussion delves into various physical and chemical approaches for stabilizing antigens in vaccine formulations, which are subsequently integrated into the MNs matrix. The primary focus is to comprehensively examine the challenges associated with the translation of thermostable vaccine MNs for clinical applications while considering a safe, cost-effective approach with a regulatory roadmap. The recent cutting-edge advances facilitating flexible and scalable manufacturing of stabilized MNs patches have been emphasized. In conclusion, the ability to stabilize vaccines and therapeutics for MNs applications could bolster the effectiveness, safety and user-compliance for various drugs and vaccines, potentially offering a substantial impact on global public health.
微米级针头，即所谓的微针（MNs），为有效的皮内免疫提供了一种微创、几乎无痛且用户友好的方法。维持抗原和治疗剂的稳定性是生产载有疫苗或药物的微针的主要挑战。微针贴片的制造涉及环境温度或更高温度下的工艺以及各种物理机械应力，这些都会影响敏感生物制品或疫苗的治疗效果。因此，开发保护微针内疫苗和其他生物制剂的技术至关重要。尽管将微针作为一种高效的疫苗递送工具的研究兴趣日益浓厚，但尚无全面综述整合为确保与微针制造兼容而保护疫苗有效载荷热稳定性的策略和努力。讨论深入探讨了在疫苗制剂中稳定抗原的各种物理和化学方法，这些方法随后被整合到微针基质中。主要重点是在考虑安全、经济有效的方法以及监管路线图的同时，全面审视与热稳定疫苗微针临床应用转化相关的挑战。文中强调了近期促进稳定微针贴片灵活且可扩展制造的前沿进展。总之，为微针应用稳定疫苗和治疗剂的能力可增强各种药物和疫苗的有效性、安全性及用户依从性，可能对全球公共卫生产生重大影响。
