Abstract
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.Graphical abstract
Highlights
Microneedle array patches (MAPs), referred to as microneedle patches, offer an alternative to injectable methods of administering drugs and biologics [1]
To determine individual and aggregate levels of manufacturing readiness in the pharmaceutical MAP industry, an online survey was distributed via email in December 2019 to academic and commercial developers
The survey was distributed to 78 MAP developer organizations, and 27 completed the survey (34.6% response rate), representing 10 countries
Summary
Microneedle array patches (MAPs), referred to as microneedle patches, offer an alternative to injectable methods of administering drugs and biologics [1]. A MAP contains tens to thousands of projections less than 1 mm long that are either coated with or composed of a dry formulation and designed to puncture the stratum corneum. There are several MAP types in development, including solid-coated, dissolving, and hydrogel that aim to administer a vaccine or drug to the dermis or epidermis. Organizations advancing pharmaceutical MAP technology include academic groups and biotechnology companies of varying sizes. The pharmaceutical industry has expressed interest in MAPs. For instance, Merck & Co., Inc., has announced a partnership with Vaxxas Inc. to develop a vaccine MAP [2], and Serum Institute of India has contributed material for MAP clinical studies for both measles-rubella and hepatitis B vaccines
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