Yongdan Wang, Saeyoung Kim, Zhen Qin, Zhao Wang, Seongkyu Yoon
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引用次数: 0
Abstract
mRNA therapeutics have emerged as a transformative platform for vaccines and protein replacement therapies, yet their broader clinical and commercial translation remains constrained by challenges in product stability, safety, potency, and delivery efficiency. This review provides a comprehensive overview of the current state of mRNA therapeutic development across the entire product lifecycle, spanning RNA design, manufacturing process optimization and characterization, scale-up and continuous manufacturing, lipid nanoparticle design, formulation, and delivery. Unlike prior reviews that focus on individual stages, we present an end-to-end perspective linking drug substance and drug product development, with emphasis on technological advances over the past 5 years. By integrating these advances, this review offers a practical roadmap for overcoming key bottlenecks and accelerating next-generation mRNA therapeutics.
期刊介绍：
Trends in Biotechnology publishes reviews and perspectives on the applied biological sciences, focusing on useful science applied to, derived from, or inspired by living systems.
The major themes that TIBTECH is interested in include:
Bioprocessing (biochemical engineering, applied enzymology, industrial biotechnology, biofuels, metabolic engineering)
Omics (genome editing, single-cell technologies, bioinformatics, synthetic biology)
Materials and devices (bionanotechnology, biomaterials, diagnostics/imaging/detection, soft robotics, biosensors/bioelectronics)
Therapeutics (biofabrication, stem cells, tissue engineering and regenerative medicine, antibodies and other protein drugs, drug delivery)
Agroenvironment (environmental engineering, bioremediation, genetically modified crops, sustainable development).
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