Intercell USA, 20 Firstfield Road, Suite 250, Gaithersburg, MD 20878, USA.
Vaccine. 2012 Jun 19;30(29):4349-54. doi: 10.1016/j.vaccine.2011.09.113.
Transcutaneous immunization (TCI) has become an attractive alternate route of immunization due to increase understanding of the skin immune system and to recent technical innovations in skin patch delivery systems. Basic principles of TCI have been demonstrated in animal and human studies, covering a variety of bacterial, viral, and cancer diseases. At Intercell, we have advanced two major platforms of TCI: 1) a needle-free vaccine delivery patch (VDP) and 2) a vaccine enhancement patch (VEP). Simplified, the VDP contains an antigen with or without an adjuvant that is administered on the skin; while the VEP contains only the adjuvant and is used in combination with an injected vaccine. In many of our TCI studies, the VDP or VEP is routinely applied on pretreated skin, in which the stratum corneum has been partially removed by mild abrasion. Recently, we have achieved technical breakthroughs in formulating and stabilizing vaccines in a dry patch format. For instance, a microplate-based screening process has been implemented to rapidly identify excipients, singularly or in combination, to stabilize biological macromolecules in patch blend formulations. A second technical innovation is our nonwoven (patch) disc matrix-supported drying technology, which allows efficient drying of our patch formulation blend to produce dry stable dosage forms of VDP or VEP. The low cost and the facileness in the manufacturing of VDP (or VEP) combined with the development of thermostable dry patches should improve the supply chain efficiency and reduce the dependence on cold chain.
经皮免疫（TCI）因其对皮肤免疫系统的深入了解以及皮肤贴片输送系统的最新技术创新，已成为一种有吸引力的替代免疫途径。TCI 的基本原理已在动物和人体研究中得到证实，涵盖了各种细菌、病毒和癌症疾病。在 Intercell 公司，我们已经开发了两种主要的 TCI 平台：1）无针疫苗输送贴片（VDP）和 2）疫苗增强贴片（VEP）。简而言之，VDP 包含抗原（含或不含佐剂），直接施用于皮肤；而 VEP 仅包含佐剂，与注射疫苗联合使用。在我们的许多 TCI 研究中，VDP 或 VEP 常规应用于预处理皮肤，其中角质层已通过轻度磨损部分去除。最近，我们在将疫苗配制成干燥贴片方面取得了技术突破。例如，我们实施了基于微板的筛选流程，以快速确定赋形剂，单独或组合使用，以稳定贴片混合物配方中的生物大分子。第二项技术创新是我们的无纺（贴片）盘基质支持干燥技术，它允许我们的贴片配方混合物高效干燥，从而产生 VDP 或 VEP 的干燥稳定剂量形式。VDP（或 VEP）制造的低成本和简易性与热稳定干燥贴片的开发相结合，应该会提高供应链效率，并减少对冷链的依赖。
