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Abstract
mRNA therapeutics face challenges in product stability, safety, potency, and delivery efficiency.
- A comprehensive overview of mRNA therapeutic development is provided, covering the entire product lifecycle.
- Key areas include RNA design, manufacturing process optimization, and lipid nanoparticle formulation.
- Technological advances over the past 5 years are highlighted as critical for mRNA product development.
- An end-to-end perspective links drug substance and drug product development to address existing challenges.
- The review offers a practical roadmap for addressing bottlenecks in mRNA therapeutics.
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