Enhancing vaccine stability in transdermal microneedle platforms.

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.