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This commentary discusses challenges in scaling oligonucleotide manufacturing, focusing on sustainability and regulatory aspects.
“The hardest things to control at scale are sequence-related impurities and batch-to-batch consistency.” Jokūbas Leikauskas, Editor, Nucleic Acid Insights, speaks to Fred Briones, Senior Director, CMC, City Therapeutics, about the challenges and opportunities of scaling oligonucleotide manufacturing to commercial volumes, with particular emphasis on sustainability, process innovation, and regulatory alignment in RNA interference (RNAi) therapeutics.
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Fred Briones (2026) studied this question.
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