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从 MAP 开发商的角度看,微阵列疫苗贴片实现商业化的机遇与挑战。

Opportunities and challenges for commercializing microarray patches for vaccination from a MAP developer's perspective.

机构信息

Research & Development, Vaxxas Pty Ltd., Brisbane, Australia.

出版信息

Hum Vaccin Immunother. 2022 Nov 30;18(4):2050123. doi: 10.1080/21645515.2022.2050123. Epub 2022 Mar 31.

Abstract

Continued advances in microarray patch (MAP) technology are starting to make needle-free delivery of a broad range of vaccines an achievable goal. The drivers and potential benefits of a MAP platform for pandemic response and routine vaccination are clear and include dose-sparing, cold-chain elimination, increased safety, and potential self-administration. MAP technology is regarded as a priority innovation to overcome vaccination barriers, ensure equitable access, and improve the effectiveness of vaccines. Vaxxas, a global leader in this technology, has built a strong evidence-base for the commercial application of their high-density (HD) MAP platform, and is rapidly advancing scale-up of the manufacturing process for HD-MAPs. A greater awareness and understanding of the implications of the technology amongst supply-chain participants, regulatory authorities, and global healthcare organizations and foundations is needed to accelerate adoption and, particularly, to prepare for MAP use in pandemics. Key challenges remain in the commercialization of MAP technology and its adoption, including market acceptance, scale-up of production, regulatory approval, and the availability of capital to build advanced manufacturing infrastructure ahead of late-stage clinical trials.

摘要

微阵列贴剂(MAP)技术的持续进步正开始使广泛的疫苗无针输送成为可能的目标。MAP 平台在应对大流行和常规疫苗接种方面的驱动力和潜在好处是显而易见的,包括节省剂量、消除冷链、提高安全性和潜在的自我管理。MAP 技术被视为克服疫苗接种障碍、确保公平获取和提高疫苗效力的优先创新。Vaxxas 是该技术的全球领导者,为其高密度(HD)MAP 平台的商业应用建立了强大的证据基础,并正在迅速推进 HD-MAP 制造工艺的规模化。需要提高供应链参与者、监管机构以及全球医疗保健组织和基金会对该技术影响的认识和理解,以加速采用,特别是为 MAP 在大流行中的使用做好准备。MAP 技术的商业化及其采用仍面临一些挑战,包括市场接受度、生产规模扩大、监管批准以及在后期临床试验之前建立先进制造基础设施的资金可用性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0eea/9196745/02e2f9030bd7/KHVI_A_2050123_F0001_OC.jpg

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