MANUFACTURING ARTICLES
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The RNA Ties That Bind: 3 Takeaways From The OPT Congress
Here, I unpack three takeaways I had from the OPT Congress, each of which I’d argue are indicative of the interconnectedness across the genetic medicines field.
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Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.
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The Potency Chains Of Events For mRNA/LNP Therapeutics
Potency in mRNA/LNP therapies depends on two chains: manufacturing/cold chain integrity and complex in vivo delivery. Breakdowns at any step — from stability to translation — can limit efficacy and safety.
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How Informal FDA Feedback Is Quietly Driving RNA Capital Allocation
Subtle FDA signals — especially in pre-IND talks — are quietly shaping RNA investment. Early regulatory feedback on CMC and comparability now drives how investors assess risk and allocate capital.
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Inside Alnylam's Playbook For High Volume siRNA Production
As one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.
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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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Explore the advantages of mRNA technology, the process steps of large-scale mRNA production, and the effect of common contaminants on mRNA manufacturing.
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Explore how Difco™ TC Yeastolate ultra-filtered (TCY UF) enabled over 100% improvement in titer for CHO cell culture through feed optimization and bioreactor scalability in a real-world application.
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Nucleic acid therapeutics offer exciting new avenues of treatment. Learn about the history of nucleic acid therapeutics and the environmental impact of manufacturing mRNA and oligonucleotides.
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Explore each intertwined step in the mRNA manufacturing process and how a flexible approach can get your mRNA product to clinic and market faster.
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Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.
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Aseptic filling is vital yet often guided by outdated practices. Discover expert insights on modern technologies, evolving regulations, and data-driven strategies to improve compliance and reduce risk in this critical manufacturing step.
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Explore the differences between research-use-only oligonucleotides and those manufactured in compliance with GMP 21 CFR 820.