{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T05:24:59Z","timestamp":1787117099696,"version":"build-2736575974"},"reference-count":272,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T00:00:00Z","timestamp":1786924800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Vaccination ranks among the most consequential interventions in medicine, yet cold-chain dependence, sharps hazards, needle phobia, and reliance on trained vaccinators limit coverage where vaccine-preventable mortality is highest. Microneedle patches deposit antigen into the antigen-presenting-cell-rich epidermis and upper dermis through projections that penetrate the stratum corneum without reaching dermal nociceptors. Such targeting yields immunogenicity matching or exceeding intramuscular injection at a fraction of the antigen mass, with dose-sparing up to six-fold recorded for influenza, polio, and SARS-CoV-2 antigens. Solid-state formulation converts that immunological advantage into a logistical one, since polymeric matrices preserve potency for as long as two years at ambient temperature, removing the refrigeration infrastructure that consumes significant delivery cost. Six microneedle types have reached preclinical or clinical maturity, with dissolving microneedle patches the most advanced. Two trials provide the clinical evidence: a Phase I influenza study showing non-inferior antibody responses and successful self-application, and a Phase I\/II measles\u2013rubella trial in The Gambia reaching 93% measles and 100% rubella seroconversion in infants without related serious adverse events. Engineering advances currently include an automated printer producing thermostable mRNA\u2013lipid nanoparticle patches that retain bioactivity for six months at ambient temperature, the first intradermal self-amplifying RNA patch, and quantum-dot on-body immunization records. Sterility assurance, dose uniformity, nucleic acid integrity within solid matrices, and fragmented regulatory guidance remain the challenging obstacles, alongside a clinical pipeline concentrated on few antigens. This review integrates the mechanistic, materials, manufacturing, clinical, regulatory, and global health dimensions of the field to guide translation and equitable deployment.<\/jats:p>","DOI":"10.3390\/pharmaceutics18081022","type":"journal-article","created":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T16:35:08Z","timestamp":1786984508000},"page":"1022","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Microneedles for Vaccination: Mechanistic Foundations, Materials Innovation, Clinical Translation, and Global Health Implementation"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2449-0281","authenticated-orcid":false,"given":"Hiep X.","family":"Nguyen","sequence":"first","affiliation":[{"name":"College of Pharmacy, California Northstate University, 9700 West Taron Drive, Elk Grove, CA 95757, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mai Phuong","family":"Ho","sequence":"additional","affiliation":[{"name":"College of Pharmacy, California Northstate University, 9700 West Taron Drive, Elk Grove, CA 95757, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,8,17]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"A99","DOI":"10.1016\/j.vaccine.2014.12.037","article-title":"Costs of Vaccine Programs across 94 Low-and Middle-Income Countries","volume":"33","author":"Portnoy","year":"2015","journal-title":"Vaccine"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"911","DOI":"10.1093\/cid\/cir007","article-title":"\u201cHerd Immunity\u201d: A Rough Guide","volume":"52","author":"Fine","year":"2011","journal-title":"Clin. Infect. Dis."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"794","DOI":"10.2471\/BLT.15.162172","article-title":"Inequalities in Full Immunization Coverage: Trends in Low-and Middle-Income Countries","volume":"94","author":"Barros","year":"2016","journal-title":"Bull. World Health Organ."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"141","DOI":"10.1016\/j.vaccine.2021.11.005","article-title":"Child Vaccination in Sub-Saharan Africa: Increasing Coverage Addresses Inequalities","volume":"40","author":"Bobo","year":"2022","journal-title":"Vaccine"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"387","DOI":"10.1038\/s41573-023-00670-0","article-title":"Overcoming Barriers to Patient Adherence: The Case for Developing Innovative Drug Delivery Systems","volume":"22","author":"Baryakova","year":"2023","journal-title":"Nat. Rev. Drug Discov."},{"key":"ref_6","first-page":"189","article-title":"The Challenge of Patient Adherence","volume":"1","author":"Martin","year":"2005","journal-title":"Ther. Clin. Risk Manag."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1511","DOI":"10.1016\/S0140-6736(17)31665-3","article-title":"Safety and Immunogenicity of a mRNA Rabies Vaccine in Healthy Adults: An Open-Label, Non-Randomised, Prospective, First-in-Human Phase 1 Clinical Trial","volume":"390","author":"Alberer","year":"2017","journal-title":"Lancet"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1186\/s40425-015-0068-y","article-title":"Self-Adjuvanted mRNA Vaccination in Advanced Prostate Cancer Patients: A First-in-Man Phase I\/IIa Study","volume":"3","author":"Scheel","year":"2015","journal-title":"J. Immunother. Cancer"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"632","DOI":"10.1016\/S0140-6736(23)02268-7","article-title":"Individualised Neoantigen Therapy mRNA-4157 (V940) plus Pembrolizumab versus Pembrolizumab Monotherapy in Resected Melanoma (KEYNOTE-942): A Randomised, Phase 2b Study","volume":"403","author":"Weber","year":"2024","journal-title":"Lancet"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"459","DOI":"10.1517\/17425247.4.5.459","article-title":"Needle-Free Vaccine Delivery","volume":"4","author":"Kersten","year":"2007","journal-title":"Expert Opin. Drug Deliv."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"723","DOI":"10.1016\/j.vaccine.2015.12.002","article-title":"Microneedle Technology for Immunisation: Perception, Acceptability and Suitability for Paediatric Use","volume":"34","author":"Marshall","year":"2016","journal-title":"Vaccine"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"2115","DOI":"10.1016\/j.vaccine.2016.11.097","article-title":"The Origins of the Vaccine Cold Chain and a Glimpse of the Future","volume":"35","author":"Lloyd","year":"2017","journal-title":"Vaccine"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1586\/erv.09.20","article-title":"Opportunities and Challenges of Developing Thermostable Vaccines","volume":"8","author":"Chen","year":"2009","journal-title":"Expert Rev. Vaccines"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"4065","DOI":"10.1016\/j.vaccine.2010.03.076","article-title":"Improving Temperature Monitoring in the Vaccine Cold Chain at the Periphery: An Intervention Study Using a 30-Day Electronic Refrigerator Temperature Logger (Fridge-Tag)","volume":"28","author":"Nelaj","year":"2010","journal-title":"Vaccine"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1258\/095646204322637182","article-title":"The Global Burden of Disease Attributable to Contaminated Injections given in Health Care Settings","volume":"15","author":"Hauri","year":"2004","journal-title":"Int. J. STD AIDS"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"137","DOI":"10.1016\/j.cld.2009.11.004","article-title":"US Outbreak Investigations Highlight the Need for Safe Injection Practices and Basic Infection Control","volume":"14","author":"Perz","year":"2010","journal-title":"Clin. Liver Dis."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1111\/jan.13818","article-title":"The Fear of Needles: A Systematic Review and Meta-Analysis","volume":"75","author":"McLenon","year":"2019","journal-title":"J. Adv. Nurs."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1586\/17434440.3.1.1","article-title":"Microneedle Array Technology: The Time Is Right but Is the Science Ready?","volume":"3","author":"Birchall","year":"2006","journal-title":"Expert Rev. Med. Devices"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"1261","DOI":"10.1038\/nbt.1504","article-title":"Transdermal Drug Delivery","volume":"26","author":"Prausnitz","year":"2008","journal-title":"Nat. Biotechnol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"199175","DOI":"10.1016\/j.virusres.2023.199175","article-title":"Establishing Immunogenicity and Safety of Needle-Free Intradermal Delivery by Nanoporous Ceramic Skin Patch of mRNA SARS-CoV-2 Vaccine as a Revaccination Strategy in Healthy Volunteers","volume":"334","author":"Prins","year":"2023","journal-title":"Virus Res."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"409","DOI":"10.1111\/jphp.12248","article-title":"Laser-Engineered Dissolving Microneedle Arrays for Protein Delivery: Potential for Enhanced Intradermal Vaccination","volume":"67","author":"McCrudden","year":"2015","journal-title":"J. Pharm. Pharmacol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"324","DOI":"10.1038\/s44222-023-00141-6","article-title":"Microneedle Biomedical Devices","volume":"2","author":"Zheng","year":"2024","journal-title":"Nat. Rev. Bioeng."},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"Nguyen, H.X. (2023). Microneedles: The Future of Drug Delivery, CRC Press.","DOI":"10.1201\/9780429294433"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1016\/j.ejpb.2018.05.017","article-title":"Poly (Vinyl Alcohol) Microneedles: Fabrication, Characterization, and Application for Transdermal Drug Delivery of Doxorubicin","volume":"129","author":"Nguyen","year":"2018","journal-title":"Eur. J. Pharm. Biopharm."},{"key":"ref_25","doi-asserted-by":"crossref","unstructured":"Nguyen, H.X., and Nguyen, C.N. (2023). Microneedle-Mediated Transdermal Delivery of Biopharmaceuticals. Pharmaceutics, 15.","DOI":"10.3390\/pharmaceutics15010277"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"1155","DOI":"10.1016\/j.jbiomech.2003.12.010","article-title":"Insertion of Microneedles into Skin: Measurement and Prediction of Insertion Force and Needle Fracture Force","volume":"37","author":"Davis","year":"2004","journal-title":"J. Biomech."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"1034","DOI":"10.3762\/bjnano.12.77","article-title":"An Overview of Microneedle Applications, Materials, and Fabrication Methods","volume":"12","author":"Rad","year":"2021","journal-title":"Beilstein J. Nanotechnol."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"5616","DOI":"10.1021\/acsabm.9b00700","article-title":"Safety Evaluation of Solid Polymer Microneedles in Human Volunteers at Different Application Sites","volume":"2","author":"Chen","year":"2019","journal-title":"ACS Appl. Bio Mater."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1208\/s12249-021-02044-4","article-title":"Formulation Approach That Enables the Coating of a Stable Influenza Vaccine on a Transdermal Microneedle Patch","volume":"22","author":"Ameri","year":"2021","journal-title":"AAPS PharmSciTech"},{"key":"ref_30","doi-asserted-by":"crossref","unstructured":"Choi, I.-J., Cha, H.-R., Kwon, D., Kang, A., Kim, J.S., Kim, J., Choi, J.-E., Chung, H.W., Park, S., and Shim, D.H. (2024). Development and Evaluation of Five-in-One Vaccine Microneedle Array Patch for Diphtheria, Tetanus, Pertussis, Hepatitis B, and Haemophilus influenzae Type b: Immunological Efficacy and Long-Term Stability. Pharmaceutics, 16.","DOI":"10.3390\/pharmaceutics16121631"},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"5954","DOI":"10.1016\/j.vaccine.2019.08.036","article-title":"Skin Immunization with Third-Generation Hepatitis B Surface Antigen Using Microneedles","volume":"37","author":"Nguyen","year":"2019","journal-title":"Vaccine"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.biomaterials.2017.02.040","article-title":"Tolerability, Usability and Acceptability of Dissolving Microneedle Patch Administration in Human Subjects","volume":"128","author":"Arya","year":"2017","journal-title":"Biomaterials"},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"7175","DOI":"10.1016\/j.vaccine.2020.07.064","article-title":"Acceptability of an Inactivated Influenza Vaccine Delivered by Microneedle Patch: Results from a Phase I Clinical Trial of Safety, Reactogenicity, and Immunogenicity","volume":"38","author":"Frew","year":"2020","journal-title":"Vaccine"},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1016\/S0140-6736(17)30575-5","article-title":"The Safety, Immunogenicity, and Acceptability of Inactivated Influenza Vaccine Delivered by Microneedle Patch (TIV-MNP 2015): A Randomised, Partly Blinded, Placebo-Controlled, Phase 1 Trial","volume":"390","author":"Rouphael","year":"2017","journal-title":"Lancet"},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"3779","DOI":"10.1016\/j.vaccine.2018.05.053","article-title":"Safety, Tolerability, Acceptability and Immunogenicity of an Influenza Vaccine Delivered to Human Skin by a Novel High-Density Microprojection Array Patch (NanopatchTM)","volume":"36","author":"Fernando","year":"2018","journal-title":"Vaccine"},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"e012247","DOI":"10.1136\/bmjgh-2023-012247","article-title":"Immunogenicity, Safety, Usability and Acceptability of Microarray Patches for Vaccination: A Systematic Review and Meta-Analysis","volume":"8","author":"Berger","year":"2023","journal-title":"BMJ Glob. Health"},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"1879","DOI":"10.1016\/S0140-6736(24)00532-4","article-title":"A Measles and Rubella Vaccine Microneedle Patch in The Gambia: A Phase 1\/2, Double-Blind, Double-Dummy, Randomised, Active-Controlled, Age de-Escalation Trial","volume":"403","author":"Adigweme","year":"2024","journal-title":"Lancet"},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1111\/srt.12082","article-title":"Comparison of the Stratum Corneum Thickness Measured in Vivo with Confocal Raman Spectroscopy and Confocal Reflectance Microscopy","volume":"20","author":"Bielfeldt","year":"2014","journal-title":"Skin Res. Technol."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"449","DOI":"10.1002\/wnan.147","article-title":"Drug Delivery through the Skin: Molecular Simulations of Barrier Lipids to Design More Effective Noninvasive Dermal and Transdermal Delivery Systems for Small Molecules, Biologics, and Cosmetics","volume":"3","author":"Sivaloganathan","year":"2011","journal-title":"Wiley Interdiscip. Rev. Nanomed. Nanobiotechnol."},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"115","DOI":"10.1038\/nrd1304","article-title":"Current Status and Future Potential of Transdermal Drug Delivery","volume":"3","author":"Prausnitz","year":"2004","journal-title":"Nat. Rev. Drug Discov."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"125874","DOI":"10.1016\/j.ijpharm.2025.125874","article-title":"Formulation, Sterilization, and Clinical Evaluation of Microneedles for Vaccine and Biologic Delivery: A Review","volume":"682","author":"Sanjanwala","year":"2025","journal-title":"Int. J. Pharm."},{"key":"ref_42","doi-asserted-by":"crossref","first-page":"395","DOI":"10.1007\/s13346-021-01045-x","article-title":"Recent Advances in Porous Microneedles: Materials, Fabrication, and Transdermal Applications","volume":"12","author":"Bao","year":"2022","journal-title":"Drug Deliv. Transl. Res."},{"key":"ref_43","doi-asserted-by":"crossref","first-page":"101923","DOI":"10.1016\/j.jddst.2020.101923","article-title":"A Review of Recent Advances in Microneedle Technology for Transdermal Drug Delivery","volume":"59","author":"Nagarkar","year":"2020","journal-title":"J. Drug Deliv. Sci. Technol."},{"key":"ref_44","doi-asserted-by":"crossref","first-page":"2513","DOI":"10.1007\/s11095-009-9967-2","article-title":"Microneedle Arrays Allow Lower Microbial Penetration than Hypodermic Needles in Vitro","volume":"26","author":"Donnelly","year":"2009","journal-title":"Pharm. Res."},{"key":"ref_45","doi-asserted-by":"crossref","unstructured":"Iredahl, F., Muller, D.A., Tog\u00f6, T., Jonasson, H., Baker, B., Anderson, C.D., and Henricson, J. (2022). Local Response and Barrier Recovery in Elderly Skin Following the Application of High-Density Microarray Patches. Vaccines, 10.","DOI":"10.3390\/vaccines10040583"},{"key":"ref_46","doi-asserted-by":"crossref","first-page":"754","DOI":"10.12968\/bjon.2024.0471","article-title":"Anatomy and Physiology of the Skin","volume":"34","author":"Harry","year":"2025","journal-title":"Br. J. Nurs."},{"key":"ref_47","doi-asserted-by":"crossref","first-page":"1080","DOI":"10.1016\/j.biopha.2016.08.026","article-title":"Transdermal Delivery of Vaccines\u2014Recent Progress and Critical Issues","volume":"83","author":"Ita","year":"2016","journal-title":"Biomed. Pharmacother."},{"key":"ref_48","doi-asserted-by":"crossref","first-page":"2461","DOI":"10.1038\/s41423-021-00726-4","article-title":"Dendritic Cell Migration in Inflammation and Immunity","volume":"18","author":"Liu","year":"2021","journal-title":"Cell. Mol. Immunol."},{"key":"ref_49","doi-asserted-by":"crossref","first-page":"965","DOI":"10.1038\/jid.2013.481","article-title":"A Three-Dimensional Atlas of Human Dermal Leukocytes, Lymphatics, and Blood Vessels","volume":"134","author":"Wang","year":"2014","journal-title":"J. Investig. Dermatol."},{"key":"ref_50","doi-asserted-by":"crossref","unstructured":"Menon, I., Bagwe, P., Gomes, K.B., Bajaj, L., Gala, R., Uddin, M.N., D\u2019souza, M.J., and Zughaier, S.M. (2021). Microneedles: A New Generation Vaccine Delivery System. Micromachines, 12.","DOI":"10.3390\/mi12040435"},{"key":"ref_51","doi-asserted-by":"crossref","first-page":"770","DOI":"10.1016\/j.imbio.2010.05.014","article-title":"Langerhans Cells and Dermal Dendritic Cells Capture Protein Antigens in the Skin: Possible Targets for Vaccination through the Skin","volume":"215","author":"Sparber","year":"2010","journal-title":"Immunobiology"},{"key":"ref_52","doi-asserted-by":"crossref","first-page":"313","DOI":"10.1586\/14760584.2016.1124762","article-title":"Molecular Mechanisms for Enhanced DNA Vaccine Immunogenicity","volume":"15","author":"Li","year":"2016","journal-title":"Expert Rev. Vaccines"},{"key":"ref_53","doi-asserted-by":"crossref","first-page":"e2501015","DOI":"10.1002\/adhm.202501015","article-title":"Microneedle-Enabled Breakthroughs in Nucleic Acid Therapeutics","volume":"14","author":"Wu","year":"2025","journal-title":"Adv. Healthc. Mater."},{"key":"ref_54","first-page":"77","article-title":"Delivery Systems for Intradermal Vaccination","volume":"351","author":"Kim","year":"2012","journal-title":"Curr. Top. Microbiol. Immunol."},{"key":"ref_55","doi-asserted-by":"crossref","first-page":"e2302410","DOI":"10.1002\/adma.202302410","article-title":"Exploiting Unique Features of Microneedles to Modulate Immunity","volume":"35","author":"Edwards","year":"2023","journal-title":"Adv. Mater."},{"key":"ref_56","doi-asserted-by":"crossref","first-page":"89","DOI":"10.1038\/s41541-021-00353-0","article-title":"Immunologic Mechanisms of Seasonal Influenza Vaccination Administered by Microneedle Patch from a Randomized Phase I Trial","volume":"6","author":"Rouphael","year":"2021","journal-title":"npj Vaccines"},{"key":"ref_57","doi-asserted-by":"crossref","first-page":"e00012-12","DOI":"10.1128\/mBio.00012-12","article-title":"Local Response to Microneedle-Based Influenza Immunization in the Skin","volume":"3","author":"Weldon","year":"2012","journal-title":"mBio"},{"key":"ref_58","doi-asserted-by":"crossref","first-page":"1159","DOI":"10.1038\/nbt1332","article-title":"Exploiting Lymphatic Transport and Complement Activation in Nanoparticle Vaccines","volume":"25","author":"Reddy","year":"2007","journal-title":"Nat. Biotechnol."},{"key":"ref_59","doi-asserted-by":"crossref","first-page":"6379","DOI":"10.1016\/j.vaccine.2011.04.080","article-title":"Targeting of HIV-P24 Particle-Based Vaccine into Differential Skin Layers Induces Distinct Arms of the Immune Responses","volume":"29","author":"Liard","year":"2011","journal-title":"Vaccine"},{"key":"ref_60","doi-asserted-by":"crossref","first-page":"266","DOI":"10.1016\/j.jconrel.2010.09.018","article-title":"Advances in Transcutaneous Vaccine Delivery: Do All Ways Lead to Rome?","volume":"148","author":"Bal","year":"2010","journal-title":"J. Control. Release"},{"key":"ref_61","doi-asserted-by":"crossref","unstructured":"Nguyen, H.X. (2025). Beyond the Needle: Innovative Microneedle-Based Transdermal Vaccination. Medicines, 12.","DOI":"10.3390\/medicines12010004"},{"key":"ref_62","doi-asserted-by":"crossref","unstructured":"Forster, A.H., Witham, K., Depelsenaire, A.C.I., Veitch, M., Wells, J.W., Wheatley, A., Pryor, M., Lickliter, J.D., Francis, B., and Rockman, S. (2020). Safety, Tolerability, and Immunogenicity of Influenza Vaccination with a High-Density Microarray Patch: Results from a Randomized, Controlled Phase I Clinical Trial. PLoS Med., 17.","DOI":"10.1371\/journal.pmed.1003024"},{"key":"ref_63","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1038\/s41541-022-00443-7","article-title":"Microneedle Patch as a New Platform to Effectively Deliver Inactivated Polio Vaccine and Inactivated Rotavirus Vaccine","volume":"7","author":"Moon","year":"2022","journal-title":"npj Vaccines"},{"key":"ref_64","doi-asserted-by":"crossref","unstructured":"Koutsonanos, D.G., del Pilar Martin, M., Zarnitsyn, V.G., Sullivan, S.P., Compans, R.W., Prausnitz, M.R., and Skountzou, I. (2009). Transdermal Influenza Immunization with Vaccine-Coated Microneedle Arrays. PLoS ONE, 4.","DOI":"10.1371\/journal.pone.0004773"},{"key":"ref_65","doi-asserted-by":"crossref","first-page":"e2110817118","DOI":"10.1073\/pnas.2110817118","article-title":"An Ultra-Low-Cost Electroporator with Microneedle Electrodes (ePatch) for SARS-CoV-2 Vaccination","volume":"118","author":"Xia","year":"2021","journal-title":"Proc. Natl. Acad. Sci. USA"},{"key":"ref_66","doi-asserted-by":"crossref","first-page":"4471","DOI":"10.1016\/j.vaccine.2018.06.025","article-title":"Enhancement of Ag85B DNA Vaccine Immunogenicity against Tuberculosis by Dissolving Microneedles in Mice","volume":"36","author":"Yan","year":"2018","journal-title":"Vaccine"},{"key":"ref_67","doi-asserted-by":"crossref","first-page":"1603228","DOI":"10.1002\/adfm.201603228","article-title":"A Novel Ultrafine Needle (UN) for Innocuous and Efficient Subcutaneous Insulin Delivery","volume":"27","author":"Li","year":"2017","journal-title":"Adv. Funct. Mater."},{"key":"ref_68","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1016\/j.ijpharm.2015.03.046","article-title":"Feasibility Study for Intraepidermal Delivery of Proteins Using a Solid Microneedle Array","volume":"486","author":"Witting","year":"2015","journal-title":"Int. J. Pharm."},{"key":"ref_69","doi-asserted-by":"crossref","first-page":"119673","DOI":"10.1016\/j.ijpharm.2020.119673","article-title":"Current Trends in Polymer Microneedle for Transdermal Drug Delivery","volume":"587","author":"Mahmood","year":"2020","journal-title":"Int. J. Pharm."},{"key":"ref_70","doi-asserted-by":"crossref","unstructured":"Aldawood, F.K., Andar, A., and Desai, S. (2021). A Comprehensive Review of Microneedles: Types, Materials, Processes, Characterizations and Applications. Polymers, 13.","DOI":"10.3390\/polym13162815"},{"key":"ref_71","doi-asserted-by":"crossref","unstructured":"Khalid, R., Mahmood, S., Mohamed Sofian, Z., Hilles, A.R., Hashim, N.M., and Ge, Y. (2023). Microneedles and Their Application in Transdermal Delivery of Antihypertensive Drugs\u2014A Review. Pharmaceutics, 15.","DOI":"10.3390\/pharmaceutics15082029"},{"key":"ref_72","doi-asserted-by":"crossref","first-page":"4093","DOI":"10.1039\/C4LC00800F","article-title":"A Flexible Microneedle Array as Low-Voltage Electroporation Electrodes for in Vivo DNA and siRNA Delivery","volume":"14","author":"Wei","year":"2014","journal-title":"Lab Chip"},{"key":"ref_73","doi-asserted-by":"crossref","first-page":"101017","DOI":"10.1016\/j.nantod.2020.101017","article-title":"Rolling Microneedle Electrode Array (RoMEA) Empowered Nucleic Acid Delivery and Cancer Immunotherapy","volume":"36","author":"Yang","year":"2021","journal-title":"Nano Today"},{"key":"ref_74","doi-asserted-by":"crossref","first-page":"3136","DOI":"10.1021\/bm1009443","article-title":"Layer-by-Layer Assembly of DNA-and Protein-Containing Films on Microneedles for Drug Delivery to the Skin","volume":"11","author":"Saurer","year":"2010","journal-title":"Biomacromolecules"},{"key":"ref_75","doi-asserted-by":"crossref","first-page":"486","DOI":"10.1007\/s13346-016-0321-z","article-title":"Development of the Novel Coating Formulations for Skin Vaccination Using Stainless Steel Microneedle","volume":"6","author":"Kim","year":"2016","journal-title":"Drug Deliv. Transl. Res."},{"key":"ref_76","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1016\/j.jconrel.2011.12.026","article-title":"Coated Microneedle Arrays for Transcutaneous Delivery of Live Virus Vaccines","volume":"159","author":"Vrdoljak","year":"2012","journal-title":"J. Control. Release"},{"key":"ref_77","doi-asserted-by":"crossref","first-page":"1547","DOI":"10.1016\/j.addr.2012.04.005","article-title":"Microneedles for Drug and Vaccine Delivery","volume":"64","author":"Kim","year":"2012","journal-title":"Adv. Drug Deliv. Rev."},{"key":"ref_78","doi-asserted-by":"crossref","first-page":"104395","DOI":"10.1016\/j.jddst.2023.104395","article-title":"Recent Advances in 3D Printed Microneedles and Their Skin Delivery Application in the Treatment of Various Diseases","volume":"84","author":"Parhi","year":"2023","journal-title":"J. Drug Deliv. Sci. Technol."},{"key":"ref_79","doi-asserted-by":"crossref","first-page":"103119","DOI":"10.1016\/j.jddst.2022.103119","article-title":"Step-Wise Micro-Fabrication Techniques of Microneedle Arrays with Applications in Transdermal Drug Delivery\u2014A Review","volume":"68","author":"Sonetha","year":"2022","journal-title":"J. Drug Deliv. Sci. Technol."},{"key":"ref_80","doi-asserted-by":"crossref","first-page":"186","DOI":"10.1016\/j.jconrel.2022.05.045","article-title":"Dissolving Microneedles: Applications and Growing Therapeutic Potential","volume":"348","author":"Sartawi","year":"2022","journal-title":"J. Control. Release"},{"key":"ref_81","doi-asserted-by":"crossref","first-page":"1249","DOI":"10.1016\/j.biopha.2018.10.078","article-title":"Microneedles: A Smart Approach and Increasing Potential for Transdermal Drug Delivery System","volume":"109","author":"Waghule","year":"2019","journal-title":"Biomed. Pharmacother."},{"key":"ref_82","doi-asserted-by":"crossref","first-page":"991","DOI":"10.1080\/21645515.2015.1010871","article-title":"Intradermal Vaccination Using the Novel Microneedle Device MicronJet600: Past, Present, and Future","volume":"11","author":"Levin","year":"2015","journal-title":"Hum. Vaccines Immunother."},{"key":"ref_83","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1016\/j.jddst.2015.05.001","article-title":"Transdermal Delivery of Drugs with Microneedles: Strategies and Outcomes","volume":"29","author":"Ita","year":"2015","journal-title":"J. Drug Deliv. Sci. Technol."},{"key":"ref_84","doi-asserted-by":"crossref","first-page":"160","DOI":"10.1208\/s12249-026-03387-6","article-title":"Microneedle-Assisted Delivery of Biologics: From Large Molecules to Cancer Vaccines","volume":"27","author":"Younas","year":"2026","journal-title":"AAPS PharmSciTech"},{"key":"ref_85","doi-asserted-by":"crossref","unstructured":"Guillot, A.J., Cordeiro, A.S., Donnelly, R.F., Montesinos, M.C., Garrigues, T.M., and Melero, A. (2020). Microneedle-Based Delivery: An Overview of Current Applications and Trends. Pharmaceutics, 12.","DOI":"10.3390\/pharmaceutics12060569"},{"key":"ref_86","doi-asserted-by":"crossref","first-page":"2000307","DOI":"10.1002\/mabi.202000307","article-title":"Hydrogel-Forming Microneedles: Current Advancements and Future Trends","volume":"21","author":"Turner","year":"2021","journal-title":"Macromol. Biosci."},{"key":"ref_87","doi-asserted-by":"crossref","first-page":"690","DOI":"10.1007\/s13346-020-00727-2","article-title":"Evaluation of the Clinical Impact of Repeat Application of Hydrogel-Forming Microneedle Array Patches","volume":"10","author":"Brady","year":"2020","journal-title":"Drug Deliv. Transl. Res."},{"key":"ref_88","doi-asserted-by":"crossref","first-page":"118","DOI":"10.1021\/acs.molpharmaceut.8b00895","article-title":"Novel Hydrogel-Forming Microneedle Array for Intradermal Vaccination in Mice Using Ovalbumin as a Model Protein Antigen","volume":"16","author":"Courtenay","year":"2019","journal-title":"Mol. Pharm."},{"key":"ref_89","doi-asserted-by":"crossref","unstructured":"Mohite, P., Puri, A., Munde, S., Ade, N., Kumar, A., Jantrawut, P., Singh, S., and Chittasupho, C. (2024). Hydrogel-Forming Microneedles in the Management of Dermal Disorders Through a Non-Invasive Process: A Review. Gels, 10.","DOI":"10.3390\/gels10110719"},{"key":"ref_90","doi-asserted-by":"crossref","unstructured":"Omidian, H., and Dey Chowdhury, S. (2025). Multifunctional Hydrogel Microneedles (HMNs) in Drug Delivery and Diagnostics. Gels, 11.","DOI":"10.3390\/gels11030206"},{"key":"ref_91","doi-asserted-by":"crossref","first-page":"133","DOI":"10.1016\/j.actbio.2022.06.015","article-title":"Intradermal Delivery of mRNA Using Cryomicroneedles","volume":"148","author":"Yu","year":"2022","journal-title":"Acta Biomater."},{"key":"ref_92","doi-asserted-by":"crossref","first-page":"3414","DOI":"10.1007\/s13346-025-01854-4","article-title":"Enhancing Vaccine Stability in Transdermal Microneedle Platforms","volume":"15","author":"Pahal","year":"2025","journal-title":"Drug Deliv. Transl. Res."},{"key":"ref_93","doi-asserted-by":"crossref","first-page":"2200905","DOI":"10.1002\/admt.202200905","article-title":"A Single-Administration Microneedle Skin Patch for Multi-Burst Release of Vaccine against SARS-CoV-2","volume":"8","author":"Tran","year":"2022","journal-title":"Adv. Mater. Technol."},{"key":"ref_94","doi-asserted-by":"crossref","first-page":"2100151","DOI":"10.1002\/anbr.202100151","article-title":"An Ultrahigh-Density Microneedle Array for Skin Vaccination: Inducing Epidermal Cell Death by Increasing Microneedle Density Enhances Total IgG and IgG1 Immune Responses","volume":"2","author":"Coffey","year":"2022","journal-title":"Adv. NanoBiomed Res."},{"key":"ref_95","doi-asserted-by":"crossref","unstructured":"Cheng, W., Wang, X., Zou, S., Ni, M., Lu, Z., Dai, L., Su, J., Yang, K., and Su, X. (2023). Fabrication of Black Silicon Microneedle Arrays for High Drug Loading. J. Funct. Biomater., 14.","DOI":"10.3390\/jfb14050245"},{"key":"ref_96","doi-asserted-by":"crossref","first-page":"97","DOI":"10.1089\/adt.2020.1022","article-title":"Microneedle Technology: An Insight into Recent Advancements and Future Trends in Drug and Vaccine Delivery","volume":"19","author":"Gupta","year":"2021","journal-title":"Assay Drug Dev. Technol."},{"key":"ref_97","doi-asserted-by":"crossref","unstructured":"Guimar\u00e3es, T.M.T., Moniz, T., Nunes, C., Zaharieva, M.M., Kaleva, M., Yoncheva, K., Najdenski, H., Costa Lima, S.A., and Reis, S. (2022). Polymeric Microneedles for Transdermal Delivery of Rivastigmine: Design and Application in Skin Mimetic Model. Pharmaceutics, 14.","DOI":"10.3390\/pharmaceutics14040752"},{"key":"ref_98","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s12039-019-1666-x","article-title":"Microneedle-Based Drug Delivery: Materials of Construction","volume":"131","author":"Bhatnagar","year":"2019","journal-title":"J. Chem. Sci."},{"key":"ref_99","doi-asserted-by":"crossref","first-page":"48","DOI":"10.1016\/j.jdin.2022.08.005","article-title":"Microneedling in the Nickel-Allergic Patient","volume":"9","author":"Margulies","year":"2022","journal-title":"JAAD Int."},{"key":"ref_100","doi-asserted-by":"crossref","unstructured":"Sargioti, N., Levingstone, T.J., O\u2019Cearbhaill, E.D., McCarthy, H.O., and Dunne, N.J. (2022). Metallic Microneedles for Transdermal Drug Delivery: Applications, Fabrication Techniques and the Effect of Geometrical Characteristics. Bioengineering, 10.","DOI":"10.3390\/bioengineering10010024"},{"key":"ref_101","first-page":"2115","article-title":"Exploring Microneedle Systems for Transdermal Drug Administration","volume":"14","author":"Sohail","year":"2024","journal-title":"J. Chem. Health Risks"},{"key":"ref_102","doi-asserted-by":"crossref","first-page":"314","DOI":"10.1016\/j.jddst.2018.01.004","article-title":"Ceramic Microneedles and Hollow Microneedles for Transdermal Drug Delivery: Two Decades of Research","volume":"44","author":"Ita","year":"2018","journal-title":"J. Drug Deliv. Sci. Technol."},{"key":"ref_103","doi-asserted-by":"crossref","first-page":"6808","DOI":"10.1039\/C8TB01476K","article-title":"Bioceramic Microneedle Arrays Are Able to Deliver OVA to Dendritic Cells in Human Skin","volume":"6","author":"Vallhov","year":"2018","journal-title":"J. Mater. Chem. B"},{"key":"ref_104","doi-asserted-by":"crossref","unstructured":"Damiri, F., Kommineni, N., Ebhodaghe, S.O., Bulusu, R., Jyothi, V.G.S.S., Sayed, A.A., Awaji, A.A., Germoush, M.O., Al-Malky, H.S., and Nasrullah, M.Z. (2022). Microneedle-Based Natural Polysaccharide for Drug Delivery Systems (DDS): Progress and Challenges. Pharmaceuticals, 15.","DOI":"10.3390\/ph15020190"},{"key":"ref_105","doi-asserted-by":"crossref","first-page":"118168","DOI":"10.1016\/j.carbpol.2021.118168","article-title":"Hyaluronic Acid Based Microneedle Array: Recent Applications in Drug Delivery and Cosmetology","volume":"267","author":"Saha","year":"2021","journal-title":"Carbohydr. Polym."},{"key":"ref_106","doi-asserted-by":"crossref","first-page":"3087","DOI":"10.1080\/10717544.2022.2125600","article-title":"The Most Promising Microneedle Device: Present and Future of Hyaluronic Acid Microneedle Patch","volume":"29","author":"Kang","year":"2022","journal-title":"Drug Deliv."},{"key":"ref_107","doi-asserted-by":"crossref","first-page":"230","DOI":"10.1016\/j.actbio.2019.07.048","article-title":"Implantable Microneedles with an Immune-Boosting Function for Effective Intradermal Influenza Vaccination","volume":"97","author":"Chen","year":"2019","journal-title":"Acta Biomater."},{"key":"ref_108","first-page":"253","article-title":"Antibacterial and Angiogenic Chitosan Microneedle Array Patch for Promoting Wound Healing","volume":"5","author":"Chi","year":"2020","journal-title":"Bioact. Mater."},{"key":"ref_109","doi-asserted-by":"crossref","first-page":"438","DOI":"10.1016\/j.ijbiomac.2021.06.059","article-title":"Chitosan-Based Microneedles as a Potential Platform for Drug Delivery through the Skin: Trends and Regulatory Aspects","volume":"184","author":"Gorantla","year":"2021","journal-title":"Int. J. Biol. Macromol."},{"key":"ref_110","doi-asserted-by":"crossref","first-page":"105574","DOI":"10.1016\/j.jddst.2024.105574","article-title":"Silk Fibroin-Based Hydrogel as Injectable Carrier for Prolonged Immunization of Plant-Based COVID-19 Subunit Vaccine","volume":"95","author":"Soomherun","year":"2024","journal-title":"J. Drug Deliv. Sci. Technol."},{"key":"ref_111","doi-asserted-by":"crossref","first-page":"8346","DOI":"10.1021\/acsami.3c16358","article-title":"Silk Fibroin-Coated Nano-MOFs Enhance the Thermal Stability and Immunogenicity of HBsAg","volume":"16","author":"Zhang","year":"2024","journal-title":"ACS Appl. Mater. Interfaces"},{"key":"ref_112","doi-asserted-by":"crossref","first-page":"1652","DOI":"10.1016\/j.vaccine.2019.12.062","article-title":"Thin Silk Fibroin Films as a Dried Format for Temperature Stabilization of Inactivated Polio Vaccine","volume":"38","author":"Stinson","year":"2020","journal-title":"Vaccine"},{"key":"ref_113","doi-asserted-by":"crossref","first-page":"5390","DOI":"10.1039\/D3BM00795B","article-title":"Recent Progress in PLGA-Based Microneedle-Mediated Transdermal Drug and Vaccine Delivery","volume":"11","author":"Abdollahi","year":"2023","journal-title":"Biomater. Sci."},{"key":"ref_114","doi-asserted-by":"crossref","first-page":"109","DOI":"10.1016\/j.jconrel.2017.09.021","article-title":"Intradermal Vaccination with Hollow Microneedles: A Comparative Study of Various Protein Antigen and Adjuvant Encapsulated Nanoparticles","volume":"266","author":"Du","year":"2017","journal-title":"J. Control. Release"},{"key":"ref_115","doi-asserted-by":"crossref","first-page":"121238","DOI":"10.1016\/j.ijpharm.2021.121238","article-title":"Spray Layering of Human Immunoglobulin G: Optimization of Formulation and Process Parameters","volume":"610","author":"Jiang","year":"2021","journal-title":"Int. J. Pharm."},{"key":"ref_116","doi-asserted-by":"crossref","first-page":"986","DOI":"10.1080\/09205063.2022.2155778","article-title":"PVP-Microneedle Array for Drug Delivery: Mechanical Insight, Biodegradation, and Recent Advances","volume":"34","author":"Mangang","year":"2023","journal-title":"J. Biomater. Sci. Polym. Ed."},{"key":"ref_117","doi-asserted-by":"crossref","first-page":"510","DOI":"10.1038\/s41587-023-01774-z","article-title":"A Microneedle Vaccine Printer for Thermostable COVID-19 mRNA Vaccines","volume":"42","author":"Sarmadi","year":"2024","journal-title":"Nat. Biotechnol."},{"key":"ref_118","doi-asserted-by":"crossref","first-page":"555","DOI":"10.1124\/jpet.119.258707","article-title":"Microneedle Coating Methods: A Review with a Perspective","volume":"370","author":"Ingrole","year":"2019","journal-title":"J. Pharmacol. Exp. Ther."},{"key":"ref_119","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1007\/s13346-016-0282-2","article-title":"Long-Term Stability of Influenza Vaccine in a Dissolving Microneedle Patch","volume":"7","author":"Mistilis","year":"2017","journal-title":"Drug Deliv. Transl. Res."},{"key":"ref_120","doi-asserted-by":"crossref","first-page":"66","DOI":"10.1016\/j.ijpharm.2019.02.035","article-title":"Excipient Selection for Thermally Stable Enveloped and Non-Enveloped Viral Vaccine Platforms in Dry Powders","volume":"561","author":"Toniolo","year":"2019","journal-title":"Int. J. Pharm."},{"key":"ref_121","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1021\/acssynbio.2c00392","article-title":"A Low-Cost, Thermostable, Cell-Free Protein Synthesis Platform for On-Demand Production of Conjugate Vaccines","volume":"12","author":"Warfel","year":"2023","journal-title":"ACS Synth. Biol."},{"key":"ref_122","doi-asserted-by":"crossref","first-page":"5507","DOI":"10.1016\/j.vaccine.2015.08.085","article-title":"Freeze-Drying of Live Virus Vaccines: A Review","volume":"33","author":"Hansen","year":"2015","journal-title":"Vaccine"},{"key":"ref_123","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1016\/j.jconrel.2009.10.013","article-title":"Formulation and Coating of Microneedles with Inactivated Influenza Virus to Improve Vaccine Stability and Immunogenicity","volume":"142","author":"Kim","year":"2010","journal-title":"J. Control. Release."},{"key":"ref_124","doi-asserted-by":"crossref","first-page":"2501","DOI":"10.1080\/21645515.2021.1887692","article-title":"Formulation Development and Improved Stability of a Combination Measles and Rubella Live-Viral Vaccine Dried for Use in the NanopatchTM Microneedle Delivery System","volume":"17","author":"Wan","year":"2021","journal-title":"Hum. Vaccines Immunother."},{"key":"ref_125","doi-asserted-by":"crossref","unstructured":"Qi, Z., Yan, Z., Tan, G., Kundu, S.C., and Lu, S. (2023). Smart Responsive Microneedles for Controlled Drug Delivery. Molecules, 28.","DOI":"10.3390\/molecules28217411"},{"key":"ref_126","doi-asserted-by":"crossref","first-page":"e2300014","DOI":"10.1002\/mabi.202300014","article-title":"Advances in Intelligent Stimuli-Responsive Microneedle for Biomedical Applications","volume":"23","author":"Xu","year":"2023","journal-title":"Macromol. Biosci."},{"key":"ref_127","unstructured":"Aguilar, M.R., and San Rom\u00e1n, J. (2019). Chapter 5\u2014Enzyme-Responsive Polymers: Classifications, Properties, Synthesis Strategies, and Applications. Smart Polymers and Their Applications, Woodhead Publishing. [2nd ed.]."},{"key":"ref_128","doi-asserted-by":"crossref","first-page":"915","DOI":"10.1038\/nm.2182","article-title":"Dissolving Polymer Microneedle Patches for Influenza Vaccination","volume":"16","author":"Sullivan","year":"2010","journal-title":"Nat. Med."},{"key":"ref_129","doi-asserted-by":"crossref","unstructured":"Aprodu, A., Mantaj, J., Raimi-Abraham, B., and Vllasaliu, D. (2019). Evaluation of a Methylcellulose and Hyaluronic Acid Hydrogel as a Vehicle for Rectal Delivery of Biologics. Pharmaceutics, 11.","DOI":"10.3390\/pharmaceutics11030127"},{"key":"ref_130","doi-asserted-by":"crossref","unstructured":"O\u2019Shea, J., Prausnitz, M.R., and Rouphael, N. (2021). Dissolvable Microneedle Patches to Enable Increased Access to Vaccines against SARS-CoV-2 and Future Pandemic Outbreaks. Vaccines, 9.","DOI":"10.3390\/vaccines9040320"},{"key":"ref_131","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1016\/j.biomaterials.2015.04.007","article-title":"Clinical Study and Stability Assessment of a Novel Transcutaneous Influenza Vaccination Using a Dissolving Microneedle Patch","volume":"57","author":"Hirobe","year":"2015","journal-title":"Biomaterials"},{"key":"ref_132","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1146\/annurev-chembioeng-060816-101514","article-title":"Engineering Microneedle Patches for Vaccination and Drug Delivery to Skin","volume":"8","author":"Prausnitz","year":"2017","journal-title":"Annu. Rev. Chem. Biomol. Eng."},{"key":"ref_133","doi-asserted-by":"crossref","first-page":"111569","DOI":"10.1016\/j.intimp.2024.111569","article-title":"Fourth Dose of Microneedle Array Patch of SARS-CoV-2 S1 Protein Subunit Vaccine Elicits Robust Long-Lasting Humoral Responses in Mice","volume":"129","author":"Kim","year":"2024","journal-title":"Int. Immunopharmacol."},{"key":"ref_134","doi-asserted-by":"crossref","unstructured":"Ansari, M.J., Rajendran, R.R., Mohanto, S., Agarwal, U., Panda, K., Dhotre, K., Manne, R., Deepak, A., Zafar, A., and Yasir, M. (2022). Poly(N-Isopropylacrylamide)-Based Hydrogels for Biomedical Applications: A Review of the State-of-the-Art. Gels, 8.","DOI":"10.3390\/gels8070454"},{"key":"ref_135","doi-asserted-by":"crossref","first-page":"308","DOI":"10.1016\/j.actbio.2022.08.061","article-title":"Thermosensitive Hydrogel Microneedles for Controlled Transdermal Drug Delivery","volume":"153","author":"Li","year":"2022","journal-title":"Acta Biomater."},{"key":"ref_136","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1016\/j.biomaterials.2018.09.008","article-title":"Smart Vaccine Delivery Based on Microneedle Arrays Decorated with Ultra-pH-Responsive Copolymers for Cancer Immunotherapy","volume":"185","author":"Duong","year":"2018","journal-title":"Biomaterials"},{"key":"ref_137","doi-asserted-by":"crossref","first-page":"390","DOI":"10.1016\/j.matt.2021.11.021","article-title":"Bioinspired Microneedle Patches: Biomimetic Designs, Fabrication, and Biomedical Applications","volume":"5","author":"Makvandi","year":"2022","journal-title":"Matter"},{"key":"ref_138","first-page":"1","article-title":"Microneedle Arrays as Transdermal and Intradermal Drug Delivery Systems: Materials Science, Manufacture and Commercial Development","volume":"104","author":"Lutton","year":"2016","journal-title":"Mater. Sci. Eng. R Rep."},{"key":"ref_139","doi-asserted-by":"crossref","first-page":"72","DOI":"10.1080\/00914037.2020.1798442","article-title":"The Hygroscopicity of Polymer Microneedles on the Performance of Dissolving Behavior for Transdermal Delivery","volume":"71","author":"Cheng","year":"2020","journal-title":"Int. J. Polym. Mater."},{"key":"ref_140","doi-asserted-by":"crossref","first-page":"82","DOI":"10.22270\/ijdra.v12i4.724","article-title":"Comparison of GMP for Drugs in EU, US, Canada, WHO and Australia","volume":"12","author":"Patil","year":"2024","journal-title":"Int. J. Drug Regul. Aff."},{"key":"ref_141","doi-asserted-by":"crossref","first-page":"164","DOI":"10.1016\/j.jconrel.2017.05.029","article-title":"Microneedles in the Clinic","volume":"260","author":"Bhatnagar","year":"2017","journal-title":"J. Control. Release"},{"key":"ref_142","doi-asserted-by":"crossref","first-page":"118992","DOI":"10.1016\/j.ijpharm.2019.118992","article-title":"Rapid Microneedle Fabrication by Heating and Photolithography","volume":"575","author":"Kathuria","year":"2020","journal-title":"Int. J. Pharm."},{"key":"ref_143","doi-asserted-by":"crossref","unstructured":"Aldawood, F.K., Andar, A., and Desai, S. (2024). Investigating Laser Ablation Process Parameters for the Fabrication of Customized Microneedle Arrays for Therapeutic Applications. Pharmaceutics, 16.","DOI":"10.3390\/pharmaceutics16070885"},{"key":"ref_144","doi-asserted-by":"crossref","first-page":"320","DOI":"10.3390\/macromol4020019","article-title":"Microneedles\u2019 Device: Design, Fabrication, and Applications","volume":"4","author":"Oliveira","year":"2024","journal-title":"Macromol"},{"key":"ref_145","doi-asserted-by":"crossref","first-page":"7309","DOI":"10.1016\/j.biomaterials.2012.06.065","article-title":"Drawing Lithography for Microneedles: A Review of Fundamentals and Biomedical Applications","volume":"33","author":"Lee","year":"2012","journal-title":"Biomaterials"},{"key":"ref_146","doi-asserted-by":"crossref","first-page":"110747","DOI":"10.1016\/j.mtcomm.2024.110747","article-title":"Development and Evaluation of Biocompatible Coated Microneedle Array for Controlled Insulin Delivery: Fabrication, Characterization, in Vitro, and in Vivo Investigations","volume":"41","author":"Anbazhagan","year":"2024","journal-title":"Mater. Today Commun."},{"key":"ref_147","doi-asserted-by":"crossref","first-page":"2059","DOI":"10.1097\/MS9.0000000000003060","article-title":"Advancements in Vaccine Delivery: Harnessing 3D Printing for Microneedle Patch Technology","volume":"87","author":"Bhadouria","year":"2025","journal-title":"Ann. Med. Surg."},{"key":"ref_148","doi-asserted-by":"crossref","first-page":"869","DOI":"10.1080\/03639045.2020.1764027","article-title":"Selective Laser Sintering 3D Printing\u2014An Overview of the Technology and Pharmaceutical Applications","volume":"46","author":"Charoo","year":"2020","journal-title":"Drug Dev. Ind. Pharm."},{"key":"ref_149","doi-asserted-by":"crossref","first-page":"743","DOI":"10.1016\/j.msec.2019.04.063","article-title":"3D Printed Microneedle Patches Using Stereolithography (SLA) for Intradermal Insulin Delivery","volume":"102","author":"Economidou","year":"2019","journal-title":"Mater. Sci. Eng. C"},{"key":"ref_150","doi-asserted-by":"crossref","first-page":"e2200278","DOI":"10.1002\/mabi.202200278","article-title":"Recent Advances in 3D Printing of Photocurable Polymers: Types, Mechanism, and Tissue Engineering Application","volume":"23","author":"Randhawa","year":"2023","journal-title":"Macromol. Biosci."},{"key":"ref_151","doi-asserted-by":"crossref","first-page":"189","DOI":"10.1208\/s12249-026-03409-3","article-title":"Emerging and Prospective Engineering Technologies Enabling Microneedle Based Vaccine Therapeutics","volume":"27","author":"Ahmad","year":"2026","journal-title":"AAPS PharmSciTech"},{"key":"ref_152","doi-asserted-by":"crossref","first-page":"102482","DOI":"10.1016\/j.apmt.2024.102482","article-title":"Low-Cost Fabrication of Digital Light Processing 3D Printed Conical Microneedles for Biomedical Applications","volume":"41","author":"Lijnse","year":"2024","journal-title":"Appl. Mater. Today"},{"key":"ref_153","doi-asserted-by":"crossref","first-page":"e2102595118","DOI":"10.1073\/pnas.2102595118","article-title":"Transdermal Vaccination via 3D-Printed Microneedles Induces Potent Humoral and Cellular Immunity","volume":"118","author":"Caudill","year":"2021","journal-title":"Proc. Natl. Acad. Sci. USA"},{"key":"ref_154","doi-asserted-by":"crossref","unstructured":"Olowe, M., Parupelli, S.K., and Desai, S. (2022). A Review of 3D-Printing of Microneedles. Pharmaceutics, 14.","DOI":"10.3390\/pharmaceutics14122693"},{"key":"ref_155","doi-asserted-by":"crossref","first-page":"3962","DOI":"10.1039\/C5LC00716J","article-title":"Vacuum-Driven Power-Free Microfluidics Utilizing the Gas Solubility or Permeability of Polydimethylsiloxane (PDMS)","volume":"15","author":"Xu","year":"2015","journal-title":"Lab Chip"},{"key":"ref_156","doi-asserted-by":"crossref","first-page":"13582","DOI":"10.1002\/anie.201809056","article-title":"Customizable Lipid Nanoparticle Materials for the Delivery of siRNAs and mRNAs","volume":"57","author":"Fenton","year":"2018","journal-title":"Angew. Chem. Int. Ed. Engl."},{"key":"ref_157","doi-asserted-by":"crossref","first-page":"e2405382121","DOI":"10.1073\/pnas.2405382121","article-title":"High-Resolution Stereolithography: Negative Spaces Enabled by Control of Fluid Mechanics","volume":"121","author":"Coates","year":"2024","journal-title":"Proc. Natl. Acad. Sci. USA"},{"key":"ref_158","doi-asserted-by":"crossref","first-page":"937","DOI":"10.1080\/14760584.2023.2270598","article-title":"Microarray Patches: Scratching the Surface of Vaccine Delivery","volume":"22","author":"Choo","year":"2023","journal-title":"Expert Rev. Vaccines"},{"key":"ref_159","doi-asserted-by":"crossref","first-page":"113944","DOI":"10.1016\/j.jconrel.2025.113944","article-title":"Lyophilized SARS-CoV-2 Self-Amplifying RNA Vaccines for Microneedle Array Patch Delivery","volume":"384","author":"Driskill","year":"2025","journal-title":"J. Control. Release"},{"key":"ref_160","doi-asserted-by":"crossref","first-page":"101700","DOI":"10.1016\/j.mtla.2023.101700","article-title":"Innovative Transdermal Drug Delivery System Based on Amoxicillin-Loaded Gelatin Methacryloyl Microneedles Obtained by 3D Printing","volume":"27","author":"Erkus","year":"2023","journal-title":"Materialia"},{"key":"ref_161","doi-asserted-by":"crossref","first-page":"130093","DOI":"10.1016\/j.optcom.2023.130093","article-title":"Fabrication of Microneedles Using Two Photon-Polymerization with Low Numerical Aperture","volume":"553","author":"He","year":"2024","journal-title":"Opt. Commun."},{"key":"ref_162","doi-asserted-by":"crossref","first-page":"110248","DOI":"10.1016\/j.msec.2019.110248","article-title":"3D Printed Microneedles for Anticancer Therapy of Skin Tumours","volume":"107","author":"Uddin","year":"2020","journal-title":"Mater. Sci. Eng. C"},{"key":"ref_163","doi-asserted-by":"crossref","first-page":"101958","DOI":"10.1016\/j.apmt.2023.101958","article-title":"A Novel Approach to the Manufacture of Dissolving Microneedles Arrays Using Aerosol Jet Printing","volume":"35","author":"Ako","year":"2023","journal-title":"Appl. Mater. Today"},{"key":"ref_164","doi-asserted-by":"crossref","first-page":"025004","DOI":"10.1088\/1758-5090\/ab5cf5","article-title":"Aerosol Jet Printing of Biological Inks by Ultrasonic Delivery","volume":"12","author":"Williams","year":"2020","journal-title":"Biofabrication"},{"key":"ref_165","doi-asserted-by":"crossref","first-page":"647","DOI":"10.1128\/CVI.00435-10","article-title":"Microneedle Vaccination with Stabilized Recombinant Influenza Virus Hemagglutinin Induces Improved Protective Immunity","volume":"18","author":"Weldon","year":"2011","journal-title":"Clin. Vaccine Immunol."},{"key":"ref_166","doi-asserted-by":"crossref","first-page":"28","DOI":"10.1016\/j.jviromet.2015.05.004","article-title":"Evaluation of Different Inactivation Methods for High and Low Pathogenic Avian Influenza Viruses in Egg-Fluids for Antigen Preparation","volume":"222","author":"Pawar","year":"2015","journal-title":"J. Virol. Methods"},{"key":"ref_167","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1016\/j.jconrel.2010.06.028","article-title":"Bioneedles as Alternative Delivery System for Hepatitis B Vaccine","volume":"147","author":"Hirschberg","year":"2010","journal-title":"J. Control. Release"},{"key":"ref_168","doi-asserted-by":"crossref","first-page":"4712","DOI":"10.1016\/j.vaccine.2015.02.074","article-title":"A Microneedle Patch Containing Measles Vaccine Is Immunogenic in Non-Human Primates","volume":"33","author":"Edens","year":"2015","journal-title":"Vaccine"},{"key":"ref_169","doi-asserted-by":"crossref","first-page":"1193","DOI":"10.1208\/s12249-010-9471-3","article-title":"Formulation of Microneedles Coated with Influenza Virus-like Particle Vaccine","volume":"11","author":"Kim","year":"2010","journal-title":"AAPS PharmSciTech"},{"key":"ref_170","doi-asserted-by":"crossref","first-page":"776","DOI":"10.1038\/nrg2432","article-title":"DNA Vaccines: Ready for Prime Time?","volume":"9","author":"Kutzler","year":"2008","journal-title":"Nat. Rev. Genet."},{"key":"ref_171","doi-asserted-by":"crossref","first-page":"865","DOI":"10.1016\/S0141-0229(03)00205-9","article-title":"Industrial Scale Production of Plasmid DNA for Vaccine and Gene Therapy: Plasmid Design, Production, and Purification","volume":"33","author":"Prather","year":"2003","journal-title":"Enzyme Microb. Technol."},{"key":"ref_172","doi-asserted-by":"crossref","first-page":"102056","DOI":"10.1016\/j.omtn.2023.102056","article-title":"Superior Efficacy of a Skin-Applied Microprojection Device for Delivering a Novel Zika DNA Vaccine","volume":"34","author":"Wijesundara","year":"2023","journal-title":"Mol. Ther. Nucleic Acids"},{"key":"ref_173","doi-asserted-by":"crossref","first-page":"567","DOI":"10.1038\/s41586-020-2622-0","article-title":"SARS-CoV-2 mRNA Vaccine Design Enabled by Prototype Pathogen Preparedness","volume":"586","author":"Corbett","year":"2020","journal-title":"Nature"},{"key":"ref_174","doi-asserted-by":"crossref","first-page":"748","DOI":"10.1021\/acscentsci.1c00197","article-title":"Modifications in an Emergency: The Role of N1-Methylpseudouridine in COVID-19 Vaccines","volume":"7","author":"Nance","year":"2021","journal-title":"ACS Cent. Sci."},{"key":"ref_175","doi-asserted-by":"crossref","first-page":"283","DOI":"10.1038\/s41586-021-03275-y","article-title":"BNT162b Vaccines Protect Rhesus Macaques from SARS-CoV-2","volume":"592","author":"Vogel","year":"2021","journal-title":"Nature"},{"key":"ref_176","doi-asserted-by":"crossref","unstructured":"Morais, P., Adachi, H., and Yu, Y.-T. (2021). The Critical Contribution of Pseudouridine to mRNA COVID-19 Vaccines. Front. Cell Dev. Biol., 9.","DOI":"10.3389\/fcell.2021.789427"},{"key":"ref_177","doi-asserted-by":"crossref","first-page":"11842","DOI":"10.1038\/s41598-018-30290-3","article-title":"Formulation, Characterization and Evaluation of mRNA-Loaded Dissolvable Polymeric Microneedles (RNApatch)","volume":"8","author":"Koh","year":"2018","journal-title":"Sci. Rep."},{"key":"ref_178","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1586\/14760584.2015.965690","article-title":"Self-Replicating Alphavirus RNA Vaccines","volume":"14","author":"Ljungberg","year":"2015","journal-title":"Expert Rev. Vaccines"},{"key":"ref_179","doi-asserted-by":"crossref","first-page":"1404","DOI":"10.1002\/eji.200737984","article-title":"Nanoparticles Target Distinct Dendritic Cell Populations According to Their Size","volume":"38","author":"Manolova","year":"2008","journal-title":"Eur. J. Immunol."},{"key":"ref_180","doi-asserted-by":"crossref","first-page":"8662","DOI":"10.1039\/D3NR00333G","article-title":"Tuning Innate Immune Function Using Microneedles Containing Multiple Classes of Toll-like Receptor Agonists","volume":"15","author":"Edwards","year":"2023","journal-title":"Nanoscale"},{"key":"ref_181","doi-asserted-by":"crossref","first-page":"165","DOI":"10.1016\/j.immuni.2005.06.008","article-title":"Suppression of RNA Recognition by Toll-like Receptors: The Impact of Nucleoside Modification and the Evolutionary Origin of RNA","volume":"23","author":"Buckstein","year":"2005","journal-title":"Immunity"},{"key":"ref_182","doi-asserted-by":"crossref","first-page":"2361","DOI":"10.1038\/jid.2014.174","article-title":"Colocalization of Cell Death with Antigen Deposition in Skin Enhances Vaccine Immunogenicity","volume":"134","author":"Depelsenaire","year":"2014","journal-title":"J. Investig. Dermatol."},{"key":"ref_183","doi-asserted-by":"crossref","unstructured":"Corbett, H.J., Fernando, G.J.P., Chen, X., Frazer, I.H., and Kendall, M.A.F. (2010). Skin Vaccination against Cervical Cancer Associated Human Papillomavirus with a Novel Micro-Projection Array in a Mouse Model. PLoS ONE, 5.","DOI":"10.1371\/journal.pone.0013460"},{"key":"ref_184","doi-asserted-by":"crossref","first-page":"2352","DOI":"10.1021\/acs.molpharmaceut.2c00919","article-title":"Single-Administration Long-Acting Microarray Patch with Ultrahigh Loading Capacity and Multiple Releases of Thermally Stable Antibodies","volume":"20","author":"Tran","year":"2023","journal-title":"Mol. Pharm."},{"key":"ref_185","doi-asserted-by":"crossref","unstructured":"Flynn, O., Dillane, K., Lanza, J.S., Marshall, J.M., Jin, J., Silk, S.E., Draper, S.J., and Moore, A.C. (2021). Low Adenovirus Vaccine Doses Administered to Skin Using Microneedle Patches Induce Better Functional Antibody Immunogenicity as Compared to Systemic Injection. Vaccines, 9.","DOI":"10.1101\/2021.01.21.427553"},{"key":"ref_186","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1016\/j.ejpb.2018.11.013","article-title":"Hyaluronan-Based Dissolving Microneedles with High Antigen Content for Intradermal Vaccination: Formulation, Physicochemical Characterization and Immunogenicity Assessment","volume":"134","author":"Leone","year":"2019","journal-title":"Eur. J. Pharm. Biopharm."},{"key":"ref_187","doi-asserted-by":"crossref","first-page":"120586","DOI":"10.1016\/j.ijpharm.2021.120586","article-title":"mRNA-Lipid Nanoparticle COVID-19 Vaccines: Structure and Stability","volume":"601","author":"Schoenmaker","year":"2021","journal-title":"Int. J. Pharm."},{"key":"ref_188","doi-asserted-by":"crossref","first-page":"19678","DOI":"10.1021\/jp063134t","article-title":"Glass Transition Temperature of Glucose, Sucrose, and Trehalose: An Experimental and in Silico Study","volume":"110","author":"Simperler","year":"2006","journal-title":"J. Phys. Chem. B"},{"key":"ref_189","doi-asserted-by":"crossref","first-page":"123688","DOI":"10.1016\/j.ijpharm.2023.123688","article-title":"Effect of Lipid Composition on RNA-Lipid Nanoparticle Properties and Their Sensitivity to Thin-Film Freezing and Drying","volume":"650","author":"AboulFotouh","year":"2024","journal-title":"Int. J. Pharm."},{"key":"ref_190","doi-asserted-by":"crossref","first-page":"1941","DOI":"10.1016\/j.ymthe.2022.02.001","article-title":"Lyophilization Provides Long-Term Stability for a Lipid Nanoparticle-Formulated, Nucleoside-Modified mRNA Vaccine","volume":"30","author":"Muramatsu","year":"2022","journal-title":"Mol. Ther."},{"key":"ref_191","doi-asserted-by":"crossref","first-page":"226","DOI":"10.1016\/j.omtn.2022.09.017","article-title":"Design and Lyophilization of Lipid Nanoparticles for mRNA Vaccine and Its Robust Immune Response in Mice and Nonhuman Primates","volume":"30","author":"Suzuki","year":"2022","journal-title":"Mol. Ther. Nucleic Acids"},{"key":"ref_192","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1038\/s41421-022-00517-9","article-title":"Lyophilized mRNA-Lipid Nanoparticle Vaccines with Long-Term Stability and High Antigenicity against SARS-CoV-2","volume":"9","author":"Ai","year":"2023","journal-title":"Cell Discov."},{"key":"ref_193","doi-asserted-by":"crossref","first-page":"1055","DOI":"10.1128\/CVI.00131-10","article-title":"Correlates of Protection Induced by Vaccination","volume":"17","author":"Plotkin","year":"2010","journal-title":"Clin. Vaccine Immunol."},{"key":"ref_194","doi-asserted-by":"crossref","first-page":"3663","DOI":"10.1016\/j.vaccine.2023.05.005","article-title":"Hepatitis B Vaccine Delivered by Microneedle Patch: Immunogenicity in Mice and Rhesus Macaques","volume":"41","author":"Choi","year":"2023","journal-title":"Vaccine"},{"key":"ref_195","doi-asserted-by":"crossref","first-page":"2132","DOI":"10.1080\/21645515.2018.1487499","article-title":"Rational Design of Heat Stable Lyophilized Rotavirus Vaccine Formulations","volume":"14","author":"Madan","year":"2018","journal-title":"Hum. Vaccine Immunother."},{"key":"ref_196","doi-asserted-by":"crossref","first-page":"19ra12","DOI":"10.1126\/scitranslmed.3000490","article-title":"Long-Term Thermostabilization of Live Poxviral and Adenoviral Vaccine Vectors at Supraphysiological Temperatures in Carbohydrate Glass","volume":"2","author":"Alcock","year":"2010","journal-title":"Sci. Transl. Med."},{"key":"ref_197","doi-asserted-by":"crossref","first-page":"24200","DOI":"10.1021\/acsnano.3c09521","article-title":"Rapid Induction of Long-Lasting Systemic and Mucosal Immunity via Thermostable Microneedle-Mediated Chitosan Oligosaccharide-Encapsulated DNA Nanoparticles","volume":"17","author":"Li","year":"2023","journal-title":"ACS Nano"},{"key":"ref_198","doi-asserted-by":"crossref","first-page":"6166","DOI":"10.1016\/j.vaccine.2021.08.016","article-title":"Micro Array Patch (MAP) for the Delivery of Thermostable Vaccines in Australia: A Cost\/Benefit Analysis","volume":"39","author":"Bozorgi","year":"2021","journal-title":"Vaccine"},{"key":"ref_199","doi-asserted-by":"crossref","first-page":"6945","DOI":"10.1016\/j.vaccine.2007.06.065","article-title":"An Economic Evaluation of Thermostable Vaccines in Cambodia, Ghana and Bangladesh","volume":"25","author":"Levin","year":"2007","journal-title":"Vaccine"},{"key":"ref_200","doi-asserted-by":"crossref","unstructured":"Garg, N., Tellier, G., Vale, N., Kluge, J., Portman, J.L., Markowska, A., and Tussey, L. (2024). Phase 1, Randomized, Rater and Participant Blinded Placebo-Controlled Study of the Safety, Reactogenicity, Tolerability and Immunogenicity of H1N1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Patch [MAP] System) in Healthy Adults. PLoS ONE, 19.","DOI":"10.1371\/journal.pone.0303450"},{"key":"ref_201","doi-asserted-by":"crossref","first-page":"124","DOI":"10.1093\/infdis\/jiy139","article-title":"A Microneedle Patch for Measles and Rubella Vaccination Is Immunogenic and Protective in Infant Rhesus Macaques","volume":"218","author":"Joyce","year":"2018","journal-title":"J. Infect. Dis."},{"key":"ref_202","doi-asserted-by":"crossref","unstructured":"Hasso-Agopsowicz, M., Crowcroft, N., Biellik, R., Gregory, C.J., Menozzi-Arnaud, M., Amorij, J.-P., Gilbert, P.-A., Earle, K., Frivold, C., and Jarrahian, C. (2022). Accelerating the Development of Measles and Rubella Microarray Patches to Eliminate Measles and Rubella: Recent Progress, Remaining Challenges. Front. Public Health, 10.","DOI":"10.3389\/fpubh.2022.809675"},{"key":"ref_203","doi-asserted-by":"crossref","first-page":"599","DOI":"10.1016\/j.medengphy.2007.06.011","article-title":"In Vivo Measurements of the Elastic Mechanical Properties of Human Skin by Indentation Tests","volume":"30","author":"Bec","year":"2008","journal-title":"Med. Eng. Phys."},{"key":"ref_204","doi-asserted-by":"crossref","first-page":"785","DOI":"10.1016\/j.biomaterials.2005.06.019","article-title":"Mechanical Properties of Human Stratum Corneum: Effects of Temperature, Hydration, and Chemical Treatment","volume":"27","author":"Wu","year":"2006","journal-title":"Biomaterials"},{"key":"ref_205","doi-asserted-by":"crossref","first-page":"32074","DOI":"10.1038\/srep32074","article-title":"A Micromechanical Comparison of Human and Porcine Skin before and after Preservation by Freezing for Medical Device Development","volume":"6","author":"Ranamukhaarachchi","year":"2016","journal-title":"Sci. Rep."},{"key":"ref_206","doi-asserted-by":"crossref","first-page":"410","DOI":"10.1080\/00015550310015419","article-title":"Epidermal Thickness at Different Body Sites: Relationship to Age, Gender, Pigmentation, Blood Content, Skin Type and Smoking Habits","volume":"83","author":"Poulsen","year":"2003","journal-title":"Acta Derm.-Venereol."},{"key":"ref_207","doi-asserted-by":"crossref","first-page":"1152","DOI":"10.1016\/j.addr.2007.07.004","article-title":"Transdermal Skin Delivery: Predictions for Humans from in Vivo, Ex Vivo and Animal Models","volume":"59","author":"Godin","year":"2007","journal-title":"Adv. Drug Deliv. Rev."},{"key":"ref_208","first-page":"47","article-title":"Review of Recent Literature on Microneedle Vaccine Delivery Technologies","volume":"3","author":"Vrdoljak","year":"2013","journal-title":"Vaccine"},{"key":"ref_209","doi-asserted-by":"crossref","first-page":"1005","DOI":"10.1152\/physrev.00037.2011","article-title":"Interstitial Fluid and Lymph Formation and Transport: Physiological Regulation and Roles in Inflammation and Cancer","volume":"92","author":"Wiig","year":"2012","journal-title":"Physiol. Rev."},{"key":"ref_210","doi-asserted-by":"crossref","first-page":"375","DOI":"10.1016\/j.ijpharm.2015.06.025","article-title":"Controlled Release of a Model Vaccine by Nanoporous Ceramic Microneedle Arrays","volume":"491","author":"Boks","year":"2015","journal-title":"Int. J. Pharm."},{"key":"ref_211","doi-asserted-by":"crossref","first-page":"4683","DOI":"10.1016\/j.vaccine.2015.01.089","article-title":"Inactivated Polio Vaccination Using a Microneedle Patch Is Immunogenic in the Rhesus Macaque","volume":"33","author":"Edens","year":"2015","journal-title":"Vaccine"},{"key":"ref_212","doi-asserted-by":"crossref","first-page":"1344","DOI":"10.1086\/651611","article-title":"Randomized Controlled Clinical Trial of Fractional Doses of Inactivated Poliovirus Vaccine Administered Intradermally by Needle-Free Device in Cuba","volume":"201","author":"Resik","year":"2010","journal-title":"J. Infect. Dis."},{"key":"ref_213","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1016\/j.jconrel.2016.08.012","article-title":"Rabies Vaccination in Dogs Using a Dissolving Microneedle Patch","volume":"239","author":"Arya","year":"2016","journal-title":"J. Control. Release"},{"key":"ref_214","doi-asserted-by":"crossref","first-page":"104922","DOI":"10.1016\/j.ebiom.2023.104922","article-title":"Safety and Immunogenicity of a Synthetic Nanoparticle-Based, T Cell Priming Peptide Vaccine against Dengue in Healthy Adults in Switzerland: A Double-Blind, Randomized, Vehicle-Controlled, Phase 1 Study","volume":"99","author":"Miauton","year":"2024","journal-title":"eBioMedicine"},{"key":"ref_215","doi-asserted-by":"crossref","first-page":"529","DOI":"10.1016\/j.jconrel.2012.07.039","article-title":"Microneedle Mediated Intradermal Delivery of Adjuvanted Recombinant HIV-1 CN54gp140 Effectively Primes Mucosal Boost Inoculations","volume":"162","author":"Pattani","year":"2012","journal-title":"J. Control. Release"},{"key":"ref_216","doi-asserted-by":"crossref","first-page":"230","DOI":"10.1016\/j.jconrel.2012.08.011","article-title":"Microneedle-Mediated Transcutaneous Immunization with Plasmid DNA Coated on Cationic PLGA Nanoparticles","volume":"163","author":"Kumar","year":"2012","journal-title":"J. Control. Release"},{"key":"ref_217","doi-asserted-by":"crossref","first-page":"1138","DOI":"10.1038\/s41467-023-36789-2","article-title":"Safety and Immunogenicity of a Thermostable ID93 + GLA-SE Tuberculosis Vaccine Candidate in Healthy Adults","volume":"14","author":"Sagawa","year":"2023","journal-title":"Nat. Commun."},{"key":"ref_218","doi-asserted-by":"crossref","first-page":"4581","DOI":"10.1021\/acsabm.0c00498","article-title":"Solid Composite Material for Delivering Viable Cells into Skin Tissues via Detachable Dissolvable Microneedles","volume":"3","author":"Pukfukdee","year":"2020","journal-title":"ACS Appl. Bio Mater."},{"key":"ref_219","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1021\/acsbiomaterials.6b00414","article-title":"In Vivo Expansion of Melanoma-Specific T Cells Using Microneedle Arrays Coated with Immune-Polyelectrolyte Multilayers","volume":"3","author":"Zeng","year":"2017","journal-title":"ACS Biomater. Sci. Eng."},{"key":"ref_220","doi-asserted-by":"crossref","first-page":"425","DOI":"10.1038\/jid.2014.415","article-title":"Dissolving Microneedle Delivery of Nanoparticle-Encapsulated Antigen Elicits Efficient Cross-Priming and Th1 Immune Responses by Murine Langerhans Cells","volume":"135","author":"Zaric","year":"2015","journal-title":"J. Investig. Dermatol."},{"key":"ref_221","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1016\/j.ejpb.2022.03.002","article-title":"Multifunctional Nanomedicines for Synergistic Photodynamic Immunotherapy Based on Tumor Immune Microenvironment","volume":"173","author":"Guo","year":"2022","journal-title":"Eur. J. Pharm. Biopharm."},{"key":"ref_222","doi-asserted-by":"crossref","first-page":"32259","DOI":"10.1021\/acsami.0c05090","article-title":"Cold to Hot: Binary Cooperative Microneedle Array-Amplified Photoimmunotherapy for Eliciting Antitumor Immunity and the Abscopal Effect","volume":"12","author":"Chen","year":"2020","journal-title":"ACS Appl. Mater. Interfaces"},{"key":"ref_223","doi-asserted-by":"crossref","first-page":"6830","DOI":"10.1039\/D1BM01117K","article-title":"Transdermal Delivery of Multifunctional CaO2@Mn-PDA Nanoformulations by Microneedles for NIR-Induced Synergistic Therapy against Skin Melanoma","volume":"9","author":"Ruan","year":"2021","journal-title":"Biomater. Sci."},{"key":"ref_224","doi-asserted-by":"crossref","first-page":"5921","DOI":"10.1021\/acsanm.1c00832","article-title":"Effective Photothermal Therapy Mediated by Indocyanine Green Nanoparticle Tip-Loaded Microneedles to Enhance Checkpoint Inhibitor Immunotherapy for Melanoma Treatment","volume":"4","author":"Yang","year":"2021","journal-title":"ACS Appl. Nano Mater."},{"key":"ref_225","doi-asserted-by":"crossref","first-page":"218","DOI":"10.1016\/j.jconrel.2020.05.006","article-title":"Construction of Microneedle-Assisted Co-Delivery Platform and Its Combining Photodynamic\/Immunotherapy","volume":"324","author":"Chen","year":"2020","journal-title":"J. Control. Release"},{"key":"ref_226","doi-asserted-by":"crossref","first-page":"480","DOI":"10.1016\/j.actbio.2019.07.003","article-title":"DNA Vaccination via RALA Nanoparticles in a Microneedle Delivery System Induces a Potent Immune Response against the Endogenous Prostate Cancer Stem Cell Antigen","volume":"96","author":"Cole","year":"2019","journal-title":"Acta Biomater."},{"key":"ref_227","doi-asserted-by":"crossref","first-page":"nwab172","DOI":"10.1093\/nsr\/nwab172","article-title":"Scattered Seeding of CAR T Cells in Solid Tumors Augments Anticancer Efficacy","volume":"9","author":"Li","year":"2022","journal-title":"Natl. Sci. Rev."},{"key":"ref_228","doi-asserted-by":"crossref","first-page":"1777","DOI":"10.1038\/s41467-017-01764-1","article-title":"Microneedle-Array Patches Loaded with Dual Mineralized Protein\/Peptide Particles for Type 2 Diabetes Therapy","volume":"8","author":"Chen","year":"2017","journal-title":"Nat. Commun."},{"key":"ref_229","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1146\/annurev-pharmtox-011711-113247","article-title":"Adherence to Medications: Insights Arising from Studies on the Unreliable Link between Prescribed and Actual Drug Dosing Histories","volume":"52","author":"Blaschke","year":"2012","journal-title":"Annu. Rev. Pharmacol. Toxicol."},{"key":"ref_230","doi-asserted-by":"crossref","first-page":"e001904","DOI":"10.1136\/bmjgh-2019-001904","article-title":"The Costs of Developing, Deploying and Maintaining Electronic Immunisation Registries in Tanzania and Zambia","volume":"4","author":"Mvundura","year":"2019","journal-title":"BMJ Glob. Health"},{"key":"ref_231","doi-asserted-by":"crossref","first-page":"794","DOI":"10.1038\/s41563-024-02115-4","article-title":"On-Patient Medical Record and mRNA Therapeutics Using Intradermal Microneedles","volume":"24","author":"Han","year":"2025","journal-title":"Nat. Mater."},{"key":"ref_232","doi-asserted-by":"crossref","first-page":"4699","DOI":"10.1016\/j.vaccine.2015.03.062","article-title":"Opportunities and Challenges in Delivering Influenza Vaccine by Microneedle Patch","volume":"33","author":"Jacoby","year":"2015","journal-title":"Vaccine"},{"key":"ref_233","doi-asserted-by":"crossref","first-page":"857","DOI":"10.3762\/bjnano.14.70","article-title":"Industrial Perspectives for Personalized Microneedles","volume":"14","author":"Richter","year":"2023","journal-title":"Beilstein J. Nanotechnol."},{"key":"ref_234","doi-asserted-by":"crossref","first-page":"2210805","DOI":"10.1002\/adfm.202210805","article-title":"Latch Applicator for Efficient Delivery of Dissolving Microneedles Based on Rapid Release of Elastic Strain Energy by Thumb Force","volume":"33","author":"Kang","year":"2023","journal-title":"Adv. Funct. Mater."},{"key":"ref_235","doi-asserted-by":"crossref","first-page":"2018863","DOI":"10.1080\/21645515.2021.2018863","article-title":"Usability, Acceptability, and Feasibility of a High-Density Microarray Patch (HD-MAP) Applicator as a Delivery Method for Vaccination in Clinical Settings","volume":"18","author":"Davies","year":"2022","journal-title":"Hum. Vaccine Immunother."},{"key":"ref_236","doi-asserted-by":"crossref","first-page":"2050123","DOI":"10.1080\/21645515.2022.2050123","article-title":"Opportunities and Challenges for Commercializing Microarray Patches for Vaccination from a MAP Developer\u2019s Perspective","volume":"18","author":"Forster","year":"2022","journal-title":"Hum. Vaccine Immunother."},{"key":"ref_237","doi-asserted-by":"crossref","first-page":"2189409","DOI":"10.1080\/21645515.2023.2189409","article-title":"Evaluation of the Self-Administration Potential of High-Density Microarray Patches to Human Skin: A Preliminary Study","volume":"19","author":"Baker","year":"2023","journal-title":"Hum. Vaccine Immunother."},{"key":"ref_238","doi-asserted-by":"crossref","first-page":"eaar2227","DOI":"10.1126\/scitranslmed.aar2227","article-title":"Cell and Fluid Sampling Microneedle Patches for Monitoring Skin-Resident Immunity","volume":"10","author":"Mandal","year":"2018","journal-title":"Sci. Transl. Med."},{"key":"ref_239","doi-asserted-by":"crossref","first-page":"2202066","DOI":"10.1002\/adhm.202202066","article-title":"Where Microneedle Meets Biomarkers: Futuristic Application for Diagnosing and Monitoring Localized External Organ Diseases","volume":"12","author":"Himawan","year":"2023","journal-title":"Adv. Healthc. Mater."},{"key":"ref_240","doi-asserted-by":"crossref","unstructured":"Park, Y.-G., Lee, S., and Park, J.-U. (2019). Recent Progress in Wireless Sensors for Wearable Electronics. Sensors, 19.","DOI":"10.3390\/s19204353"},{"key":"ref_241","doi-asserted-by":"crossref","first-page":"1214","DOI":"10.1038\/s41551-022-00887-1","article-title":"An Integrated Wearable Microneedle Array for the Continuous Monitoring of Multiple Biomarkers in Interstitial Fluid","volume":"6","author":"Tehrani","year":"2022","journal-title":"Nat. Biomed. Eng."},{"key":"ref_242","doi-asserted-by":"crossref","first-page":"3999","DOI":"10.1038\/s41467-022-31740-3","article-title":"Programmable CRISPR-Cas9 Microneedle Patch for Long-Term Capture and Real-Time Monitoring of Universal Cell-Free DNA","volume":"13","author":"Yang","year":"2022","journal-title":"Nat. Commun."},{"key":"ref_243","doi-asserted-by":"crossref","first-page":"477","DOI":"10.1038\/s41577-019-0165-0","article-title":"The NLRP3 Inflammasome: Molecular Activation and Regulation to Therapeutics","volume":"19","author":"Swanson","year":"2019","journal-title":"Nat. Rev. Immunol."},{"key":"ref_244","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1208\/s12249-022-02250-8","article-title":"Microneedle-Based Vaccine Delivery: Review of an Emerging Technology","volume":"23","author":"Mansoor","year":"2022","journal-title":"AAPS PharmSciTech"},{"key":"ref_245","doi-asserted-by":"crossref","first-page":"402","DOI":"10.1016\/j.jconrel.2024.11.056","article-title":"White Paper: Understanding, Informing and Defining the Regulatory Science of Microneedle-Based Dosage Forms That Are Applied to the Skin","volume":"378","author":"Dul","year":"2025","journal-title":"J. Control. Release"},{"key":"ref_246","doi-asserted-by":"crossref","first-page":"313","DOI":"10.1007\/s13346-015-0237-z","article-title":"Microneedle Characterisation: The Need for Universal Acceptance Criteria and GMP Specifications When Moving towards Commercialisation","volume":"5","author":"Lutton","year":"2015","journal-title":"Drug Deliv. Transl. Res."},{"key":"ref_247","unstructured":"(2013). Sterilization of Health Care Products\u2013Radiation\u2013Part 2: Establishing the Sterilization Dose (Standard No. ISO 11137-2: 2012)."},{"key":"ref_248","doi-asserted-by":"crossref","first-page":"997","DOI":"10.1016\/j.xphs.2020.12.006","article-title":"Addressing the Cold Reality of mRNA Vaccine Stability","volume":"110","author":"Crommelin","year":"2021","journal-title":"J. Pharm. Sci."},{"key":"ref_249","doi-asserted-by":"crossref","first-page":"857","DOI":"10.3109\/03639049709148693","article-title":"Influence of Irradiation Sterilization on Polymers Used as Drug Carriers\u2014A Review","volume":"23","author":"Sintzel","year":"1997","journal-title":"Drug Dev. Ind. Pharm."},{"key":"ref_250","first-page":"54","article-title":"Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products. (Highlights from the New PDA Technical Report No. 34)","volume":"13","author":"Madsen","year":"2001","journal-title":"Pharm. Technol. Eur."},{"key":"ref_251","unstructured":"US Pharmacopeia (USP), and United States Pharmacopeia\u2013National Formulary (USP-NF) (2011). <905> Uniformity of Dosage Units, United States Pharmacopeia and National Formulary (USP-NF)."},{"key":"ref_252","doi-asserted-by":"crossref","first-page":"4879","DOI":"10.1002\/adfm.201200864","article-title":"Hydrogel-Forming Microneedle Arrays for Enhanced Transdermal Drug Delivery","volume":"22","author":"Donnelly","year":"2012","journal-title":"Adv. Funct. Mater."},{"key":"ref_253","doi-asserted-by":"crossref","first-page":"593","DOI":"10.1016\/j.ijpharm.2015.01.038","article-title":"Inkjet Printing of Transdermal Microneedles for the Delivery of Anticancer Agents","volume":"494","author":"Uddin","year":"2015","journal-title":"Int. J. Pharm."},{"key":"ref_254","unstructured":"U.S. Food and Drug Administration (2026, August 14). Guidance for Industry, PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, Available online: www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/pat-framework-innovative-pharmaceutical-development-manufacturing-and-quality-assurance."},{"key":"ref_255","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1021\/op500261y","article-title":"Assessment of Recent Process Analytical Technology (PAT) Trends: A Multiauthor Review","volume":"19","author":"Simon","year":"2015","journal-title":"Org. Process Res. Dev."},{"key":"ref_256","doi-asserted-by":"crossref","first-page":"7992","DOI":"10.1021\/ac070549h","article-title":"Implementation of a Process Analytical Technology System in a Freeze-Drying Process Using Raman Spectroscopy for in-Line Process Monitoring","volume":"79","author":"Goethals","year":"2007","journal-title":"Anal. Chem."},{"key":"ref_257","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1007\/s40268-016-0144-x","article-title":"Assessing the Potential Cost-Effectiveness of Microneedle Patches in Childhood Measles Vaccination Programs: The Case for Further Research and Development","volume":"16","author":"Adhikari","year":"2016","journal-title":"Drugs RD"},{"key":"ref_258","doi-asserted-by":"crossref","unstructured":"Seaman, C.P., Mvundura, M., Frivold, C., Morgan, C., Jarrahian, C., Howell, J., Hellard, M., and Scott, N. (2022). Evaluating the Potential Cost-Effectiveness of Microarray Patches to Expand Access to Hepatitis B Birth Dose Vaccination in Low-and Middle-Income Countries: A Modelling Study. PLoS Glob. Public Health, 2.","DOI":"10.1371\/journal.pgph.0000394"},{"key":"ref_259","doi-asserted-by":"crossref","first-page":"3597","DOI":"10.1007\/s10311-021-01256-1","article-title":"Advanced Packaging for Distribution and Storage of COVID-19 Vaccines: A Review","volume":"19","author":"Ramakanth","year":"2021","journal-title":"Environ. Chem. Lett."},{"key":"ref_260","unstructured":"(2026, July 06). Vaccine Innovation Prioritisation Strategy (VIPS). Available online: https:\/\/www.gavi.org\/our-work\/market-shaping\/vaccine-innovation-prioritisation-strategy-vips."},{"key":"ref_261","doi-asserted-by":"crossref","first-page":"4435","DOI":"10.1016\/j.vaccine.2019.02.079","article-title":"End-User Acceptability Study of the NanopatchTM; a Microarray Patch (MAP) for Child Immunization in Low and Middle-Income Countries","volume":"37","author":"Guillermet","year":"2019","journal-title":"Vaccine"},{"key":"ref_262","doi-asserted-by":"crossref","first-page":"4427","DOI":"10.1016\/j.vaccine.2019.03.035","article-title":"Potential Use of Microarray Patches for Vaccine Delivery in Low- and Middle- Income Countries","volume":"37","author":"Peyraud","year":"2019","journal-title":"Vaccine"},{"key":"ref_263","doi-asserted-by":"crossref","first-page":"305","DOI":"10.1111\/srt.13131","article-title":"Micropuncture Closure Following High Density Microarray Patch Application in Healthy Subjects","volume":"28","author":"Henricson","year":"2022","journal-title":"Skin Res. Technol."},{"key":"ref_264","doi-asserted-by":"crossref","first-page":"4896","DOI":"10.1016\/j.vaccine.2017.07.083","article-title":"Acceptability of Microneedle-Patch Vaccines: A Qualitative Analysis of the Opinions of Parents","volume":"35","author":"Marshall","year":"2017","journal-title":"Vaccine"},{"key":"ref_265","doi-asserted-by":"crossref","first-page":"187","DOI":"10.3109\/10717541003667798","article-title":"Microneedle-Based Drug Delivery Systems: Microfabrication, Drug Delivery, and Safety","volume":"17","author":"Donnelly","year":"2010","journal-title":"Drug Deliv."},{"key":"ref_266","doi-asserted-by":"crossref","first-page":"1352","DOI":"10.1016\/j.promfg.2017.09.114","article-title":"Development of a Novel Single-Use Microneedle Design Platform for Increased Patient Compliance","volume":"13","author":"Bryan","year":"2017","journal-title":"Procedia Manuf."},{"key":"ref_267","doi-asserted-by":"crossref","first-page":"350","DOI":"10.1016\/j.jconrel.2021.09.036","article-title":"Microneedle Patch Designs to Increase Dose Administered to Human Subjects","volume":"339","author":"Li","year":"2021","journal-title":"J. Control. Release"},{"key":"ref_268","doi-asserted-by":"crossref","first-page":"eadd3197","DOI":"10.1126\/sciadv.add3197","article-title":"Glucose-Responsive Microneedle Patch for Closed-Loop Dual-Hormone Delivery in Mice and Pigs","volume":"8","author":"Yang","year":"2022","journal-title":"Sci. Adv."},{"key":"ref_269","doi-asserted-by":"crossref","unstructured":"Campa, C., Pronce, T., Paludi, M., Weusten, J., Conway, L., Savery, J., Richards, C., and Cl\u00e9net, D. (2021). Use of Stability Modeling to Support Accelerated Vaccine Development and Supply. Vaccines, 9.","DOI":"10.3390\/vaccines9101114"},{"key":"ref_270","doi-asserted-by":"crossref","first-page":"6206","DOI":"10.1016\/j.vaccine.2023.08.012","article-title":"Statistical Considerations on Real Time and Extended Controlled Temperature Conditions (ECTC) Stability Data Analysis of Vaccines","volume":"41","author":"Kim","year":"2023","journal-title":"Vaccine"},{"key":"ref_271","doi-asserted-by":"crossref","first-page":"2206406","DOI":"10.1002\/adfm.202206406","article-title":"A Smart Silk-Based Microneedle for Cancer Stem Cell Synergistic Immunity\/Hydrogen Therapy","volume":"32","author":"Yang","year":"2022","journal-title":"Adv. Funct. Mater."},{"key":"ref_272","doi-asserted-by":"crossref","first-page":"366","DOI":"10.1038\/s41586-018-0812-9","article-title":"Tissue-Resident Memory CD8+ T Cells Promote Melanoma-Immune Equilibrium in Skin","volume":"565","author":"Park","year":"2019","journal-title":"Nature"}],"container-title":["Pharmaceutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1999-4923\/18\/8\/1022\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T04:36:08Z","timestamp":1787114168000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1999-4923\/18\/8\/1022"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,17]]},"references-count":272,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2026,8]]}},"alternative-id":["pharmaceutics18081022"],"URL":"https:\/\/doi.org\/10.3390\/pharmaceutics18081022","relation":{},"ISSN":["1999-4923"],"issn-type":[{"value":"1999-4923","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,17]]}}}