MANUFACTURING ARTICLES
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The "Middle Ground" Advantage: Why Alnylam Is Betting Big On Chemoenzymatic Ligation
Though conversations are picking up around this hybrid approach, we aren’t exactly known as an industry that embraces risk no-holds barred. While there are a handful of manufacturers and CDMOs who are embracing the hybrid model today, there are many more that are likely to hold out for the next-next gen approach: Fully enzymatic oligo production. However, as Alynlam’s CTO and Chief Quality Officer Tim Maines argued, embarking into the “middle ground” of enzymatic ligation is essential for garnering the step-by-step learnings needed to help us unlock even bigger manufacturing wins in the future.
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The Evolution Of Oligonucleotide Manufacturing: Engineering Considerations For Scale, Efficiency, And Facility Design
As oligos move toward larger indications, manufacturing shifts from chemistry alone to facility design—balancing scale, solvent safety, cost, and flexibility as SPOS, slurry, and enzymatic paths converge.
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2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture Trends
As RNA investing matures, capital is flowing toward delivery, durability, and regulatory credibility. This column breaks down the deals, IPO signals, and venture theses shaping RNA’s 2026 winners—and why.
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Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control
Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.
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The mRNA Supply Chain Revolution: Materials, Methods, And Momentum
mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.
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A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?
In 2026, advanced therapies diverge: winners pair proven biology with scalable manufacturing, delivery, and workflow fit, while others advance more slowly under operational and economic limits.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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We offer comprehensive analytical support across the R&D space, including method development, validation, process characterization, in-process testing, process validation, and GMP release testing.
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Mastering IVT yield requires balancing magnesium and nucleotide ratios. Learn how specific buffers and pyrophosphatase optimize mRNA synthesis for scalable, high-quality therapeutic production.
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Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
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Venkata Indurthi, Ph.D., discusses key considerations for the production of RNA and strategies for successful scaling for commercial manufacture. Learn more about messenger RNA and self-amplifying RNA manufacturing processes.
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Explore an automated, compliance-ready LC-MS workflow for intact mass confirmation and purity analysis of synthetic oligonucleotides including siRNA and large single guide RNA oligonucleotides.
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Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment (DoE) approach.
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What sustainable manufacturing processes best address Oligonucleotide environmental impact while maintaining scalability?