The manufacturing gap in RNA’s therapeutic revolution
Nucleic Acid Insights 2026; 3(8), 583–594
DOI: 10.18609/nai.2026.076
RNA technology is transforming modern medicine, with approved products spanning mRNA, siRNA, antisense oligonucleotides and aptamers. The recent success of an individualized mRNA cancer immunotherapy underscores this potential but also exposes a fundamental challenge: manufacturing. RNA’s structural heterogeneity complicates process development, quality control, and regulatory compliance, and as applications expand from population-scale vaccines to fully individualized medicines, manufacturing must accommodate increasingly diverse requirements while remaining economically viable. We argue for a shift from fixed-process toward adaptive, fit-for-purpose manufacturing, integrating real-time process data, process analytical technology, and real-time release testing to support dynamic decision-making. Such frameworks offer greater flexibility, fewer batch failures, and just-in-time production, but depend on robust process understanding, collaborative knowledgesharing, and, where the product demands it, decentralized manufacturing platforms. These together will move RNA manufacturing from fixed processes toward intelligent, data-driven systems suited to everything from mass production to true personalization.