Advances in mRNA-Based Vaccines and RNA-Engineered T Cell Therapeutics: Regulatory Frameworks, Technological Innovations, and Translational Challenges
Dr. Elena Kovács , Department of Biomedical Sciences, University of Debrecen, HungaryAbstract
Messenger RNA (mRNA)-based technologies have emerged as transformative tools in modern medicine, particularly in vaccine development and cellular immunotherapy. This research article provides a comprehensive and theoretically enriched analysis of mRNA-based vaccines and RNA-engineered T cell therapeutics, grounded strictly in regulatory frameworks and experimental studies referenced in the European Pharmacopoeia and seminal molecular therapy literature. The study explores the structural, functional, and translational dynamics of mRNA substances, DNA templates, and vaccine constructs, alongside advancements in RNA electroporation for T cell modification. Emphasis is placed on the dual paradigm of transient and stable expression systems in therapeutic design, highlighting their implications in oncology and infectious disease management. The methodology adopts an integrative analytical approach, synthesizing regulatory standards with experimental findings to derive conceptual models of efficacy, safety, and scalability. Results indicate that while mRNA platforms offer unparalleled flexibility and rapid adaptability, challenges persist in delivery optimization, immune modulation, and long-term stability. The discussion critically evaluates these limitations, proposing future directions in nanotechnology, regulatory harmonization, and personalized medicine. This article contributes to the growing body of knowledge by bridging pharmacopoeial guidelines with translational research, offering a nuanced perspective on the future trajectory of mRNA-based therapeutics.
Keywords
mRNA vaccines, RNA electroporation, T cell engineering, mmunotherapy, lipid nanoparticles, gene expression, regulatory standards
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Copyright (c) 2026 Dr. Elena Kovács

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