ArticleDrug delivery and translational research2022
Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing.
Article in Drug delivery and translational research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 45 citations in OpenAlex.
- Advancing intradermal vaccine delivery: Focus on hollow microneedles and skin models.Human vaccines & immunotherapeutics · 2026Review
- Research advances in microneedle-exosome delivery systems for the treatment of multisystem diseases.Regenerative therapy · 2026Review
- Water-Soluble, Enzyme-Degradable, and Hydrolyzable STAR Particles for Enhanced Drug Delivery to Skin.Advanced healthcare materials · 2026Article
- Integrating Polymeric 3D-Printed Microneedles with Wearable Devices: Toward Smart and Personalized Healthcare Solutions.Polymers · 2025Review
- Systematic Development and Characterization of Enzyme-Free, Borax-Crosslinked Microneedles for Glucose-Responsive Insulin Delivery and In Vivo Glycemic Mitigation.Pharmaceutics · 2025Article
- Enhancing vaccine stability in transdermal microneedle platforms.Drug delivery and translational research · 2025Review
- Polymeric 3D-Printed Microneedle Arrays for Non-Transdermal Drug Delivery and Diagnostics.Polymers · 2025Review
- Advancements in Materials for 3D-Printed Microneedle Arrays: Enhancing Performance and Biocompatibility.Micromachines · 2024Review
- Article
- Cutting-edge microneedle innovations: Transforming the landscape of cardiovascular and metabolic disease management.iScience · 2024Review
- Chrono-tailored drug delivery systems: recent advances and future directions.Drug delivery and translational research · 2024Review
- Microneedle Sensors for Point-of-Care Diagnostics.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Review
- A microneedle vaccine printer for thermostable COVID-19 mRNA vaccines.Nature biotechnology · 2024Article
- Mechanical Characterization of Dissolving Microneedles: Factors Affecting Physical Strength of Needles.Pharmaceutics · 2024Article
- Evaluation of the self-administration potential of high-density microarray patches to human skin: A preliminary study.Human vaccines & immunotherapeutics · 2023Article
- Microneedle-based interstitial fluid extraction for drug analysis: Advances, challenges, and prospects.Journal of pharmaceutical analysis · 2023Review
- Industrial perspectives for personalized microneedles.Beilstein journal of nanotechnology · 2023Article
- Promising Strategies for Transdermal Delivery of Arthritis Drugs: Microneedle Systems.Pharmaceutics · 2022Review
- Ozone as a method for decontamination of dissolving microneedles for clinical use.Photochemistry and photobiologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.