[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-432735-105":59,"doc-detail-432735-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","mrna-vaccines-immunogenicity-and-quality-characteristics","mRNA vaccines - immunogenicity and quality characteristics","","mRNA vaccine technology has advanced rapidly and is now central to modern vaccine development. A quality control framework grounded in Critical Quality Attributes (CQAs) is essential for ensuring both efficacy and safety. This paper reviews key quality attributes of mRNA vaccines and analyzes how they shape immune responses. It covers technical principles, development status, major quality control items, their significance, and measurable immunogenicity indicators, emphasizing CQAs–immunogenicity correlations.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/mrna-vaccines-immunogenicity-and-quality-characteristics/432735/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/mrna-vaccines-immunogenicity-and-quality-characteristics/432735.png","ImageObject",300,407,{"name":92,"@type":93},"Fans","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-03","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":24},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"Why are Critical Quality Attributes (CQAs) important for mRNA vaccines?","Question",{"text":112,"@type":113},"CQAs provide the basis for quality control that supports vaccine efficacy and safety. 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Delivery system physicochemical properties, together with encapsulation efficiency and injectable parameters, determine in vivo delivery and are linked to immune response measures such as antibody titers and cellular responses.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},432735,1791116505,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":24,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},5909892330395,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","Quan et al. Journal of Nanobiotechnology (2026) 24:6 Journal of Nanobiotechnology  \n[https://doi.org/10.1186/s12951-025-03800-5](https://doi.org/10.1186/s12951-025-03800-5)  \nREVIEW Open Access  \nmRNA vaccines: immunogenicity and quality characteristics  \nYaru Quan 1, Huijie Yang2, Wei Li2* and Linxian Li3,4,5,6*  \nAbstract  \nmRNA vaccine technology platform has evolved rapidly in recent years, which has emerged as an important direction in vaccine development. Establishing a quality control platform based on its Critical Quality Attributes (CQAs) is fundamental to ensuring vaccine efficacy and safety. This paper systematically explores the key quality attributes of mRNA vaccines and their impact on vaccine immunogenicity. Additionally, it introduces the technical principles, development status, key quality control items and their significance, as well as immunogenicity indicators of mRNA vaccines, and discusses the critical importance of studying the correlation between CQAs and immunogenicity.  \nKeywords mRNA vaccine, Critical quality attributes, Vaccine efficacy, Safety, Vaccine immunogenicity  \n*Correspondence:  \nWei Li [yxwslw@walvax.com](yxwslw@walvax.com)[ ](yxwslw@walvax.com)Linxian Li[lxli@surgery.cuhk.edu.hk](lxli@surgery.cuhk.edu.hk)  \nFull list of author information is available at the end of the article  \n© The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit [http://creativecommons.org/l](http://creativecommons.org/l)icenses/by/4.0/.  \nQuan et al. Journal of Nanobiotechnology (2026) 24:6 Page 2 of 35  \nGraphical abstract  \nIntroduction  \nmRNA is a natural biological molecule utilize the host cell’s protein translation machinery to produce target antigens or other functional proteins, thereby providing preventive or therapeutic effects. The successful translation of mRNA vaccine research into clinical applications has depended on systematic breakthroughs in three key areas: delivery vector innovation, sequence modification technologies, and GMP production systems. For example, the incorporation of the modified nucleotide 1-methylpseudouridine in Moderna and BioNTech’s mRNA vaccines significantly reduced the innate immunogenicity of in vitro-synthesized mRNA while enhancing translation efficiency, ensuring optimal intracellular function of mRNA molecules [1, 2]. Furthermore, advances in cationic lipid development and Lipid Nanoparticle (LNP) technology have enabled efficient encapsulation of mRNA molecules and stable in vivo delivery. In optimizing mRNA molecules, co-transcriptional capping technology—particularly the Cap1 structure synthesized using trinucleotide cap analogs—has achieved efficient capping, further improving mRNA translation initiation efficiency [3]. These technological advances have facilitated the successful market launch of multiple mRNA vaccines, including BNT162b2 (BioNTech-Pfizer) and mRNA-1273 (Moderna) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), as well as  \nmRNA-1345 (Moderna) for Respiratory Syncytial Virus (RSV).  \nAdditionally, the saRNA vaccine ARCT-154—jointly developed by Arcturus Therapeutics and CSL—for SARSCoV-2 enhances vaccine efficacy by extending intracellular half-life and has received marketing","cbCaipxWNypHeXHg","https://ap.wps.com/l/cbCaipxWNypHeXHg","pdf",4774753,35,"English","# Introduction\n## mRNA vaccine technology and clinical translation\n## Quality attributes (CQAs) and immune outcomes\n## Key CQA categories and examples","[{\"question\":\"Why are Critical Quality Attributes (CQAs) important for mRNA vaccines?\",\"answer\":\"CQAs provide the basis for quality control that supports vaccine efficacy and safety. They help maintain quality consistency across production and administration.\"},{\"question\":\"Which main categories of CQAs are described for mRNA vaccines?\",\"answer\":\"CQAs are grouped into mRNA molecular characteristics, delivery system properties (e.g., LNP composition and particle properties), and general parameters for injectables such as appearance, osmolality, sterility, and pH.\"},{\"question\":\"How do CQAs influence mRNA vaccine immunogenicity?\",\"answer\":\"mRNA integrity and chemical modifications affect antigen expression efficiency and immunogenicity. Delivery system physicochemical properties, together with encapsulation efficiency and injectable parameters, determine in vivo delivery and are linked to immune response measures such as antibody titers and cellular responses.\"}]","mRNA vaccines - immunogenicity and quality characteristics | PDF",1790661023,88]