PATH (Medical Devices and Health Technologies Program), Seattle, WA, USA.
Drug Deliv Transl Res. 2022 Feb;12(2):368-375. doi: 10.1007/s13346-021-01076-4. Epub 2021 Oct 15.
Microneedle array patch (MAP) technology is a promising new delivery technology for vaccines and pharmaceuticals, yet due to several differing and novel production methods, barriers to full-scale manufacturing exist. PATH conducted a manufacturing readiness assessment and follow-up interviews to identify both the current manufacturing readiness of the industry as well as how readiness varies by developer type and MAP type. Follow-up interviews identified barriers the industry faces in reaching full manufacturing readiness, including the perceived regulatory and investment risk of manufacturing MAPs at scale due to quality requirements and control methods, uncertain sterility requirements, lack of standard production methods (especially around dissolvable MAP drying methods), and the lack of available contract manufacturing organizations with MAP manufacturing capabilities. A Regulatory Working Group has been established to identify and address critical quality issues specific to MAP manufacturing with the aim of providing developers insight into what will be expected for MAP product approvals. Standardizing MAP production equipment and automatic, visual quality control could reduce the overall investment risk to developers and contract manufacturing organizations in pursuing pilot-scale manufacturing capabilities and ultimately lower barriers to the scale-up of full medical MAP product lines.
微针贴片（MAP）技术是一种很有前途的新型疫苗和药物输送技术，但由于有几种不同且新颖的生产方法，大规模生产仍存在障碍。PATH 进行了制造准备情况评估和后续访谈，以确定行业目前的制造准备情况，以及不同开发者类型和 MAP 类型的准备情况有何不同。后续访谈确定了行业在实现全面制造准备方面面临的障碍，包括由于质量要求和控制方法，大规模制造 MAP 的监管和投资风险，不确定的无菌要求，缺乏标准的生产方法（尤其是可溶解 MAP 干燥方法），以及缺乏具有 MAP 制造能力的合同制造组织。已经成立了一个监管工作组，以确定和解决与 MAP 制造相关的关键质量问题，目的是为开发者提供有关 MAP 产品批准的预期信息。标准化 MAP 生产设备和自动、可视化质量控制可以降低开发者和合同制造组织在追求试点生产能力方面的总体投资风险，并最终降低全面医疗 MAP 产品线扩大规模的障碍。
