MANUFACTURING ARTICLES
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![Genetic engineering, dna-GettyImages-1310083278]( "Oligonucleotide Therapeutics At Scale: Bottlenecks, Breakthroughs, And What Comes Next")
Oligonucleotide Therapeutics At Scale: Bottlenecks, Breakthroughs, And What Comes NextOligonucleotide therapies have proven clinical value, but scaling beyond rare disease remains hard. William Soliman, Ph.D., BCMAS, breaks down the manufacturing, delivery, and CMC realities shaping what comes next.
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![Potter at work-GettyImages-1142834523]( "Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026")
Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026Here, in part two of this multi-part series, we hear from Melissa Bonner, CSO of nChroma Bio and Andy Geall, CDO of Replicate Biosciences, who call attention to several developments of the past year they’ve been watching and how they see these developments informing our conversations about and work with mRNA in 2026 and beyond.
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![Medical syringe with blue glass DNA helix-GettyImages-1631239019]( "To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem")
To Fight Cancer, Gene Editing Needs To Solve Its Delivery ProblemThe choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.
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![business challenge, risk-GettyImages-2200659695]( "Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next Chapter")
Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next ChapterNow, I cannot claim that I or any of the panelists at CASSS have or had access to a real crystal ball that will show us the future. However, what did come through these discussions loud and clear is that the future of our industry must include “balance.” Here, I’ll unpack a few ways the theme of “balance” presented itself — and no doubt will continue to present itself in the future — as well as how the panelists see us achieving this necessary balance.
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![path of exponential growth-GettyImages-2229192052]( "Trends In Oligo Scale-Up & Delivery & How They're Impacting Manufacturing")
Trends In Oligo Scale-Up & Delivery & How They're Impacting ManufacturingHere, a panel of experts at the RNA Leaders Conference gives a fantastic overview of where we are today and why, as one expert so nicely put it, “This is one of the most fun times to be an oligo scientist or chemist.”
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![Utility teamwork-GettyImages-2211320040]( "From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy")
From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA PolicyIn this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact.
MANUFACTURING VIDEOS
Featured speakers for the "Got Raw Materials? The State Of The mRNA Supply Chain" event share how they are working to deepen their partnerships today.
Hosted by Cell & Gene Collaborative's Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 2, Welch outlines how The Game of RISK can serve as a great example for the mRNA therapeutics industry in its long-term quest to standardize the mRNA drug product manufacturing paradigm.
Learn how membrane chromatography can help overcome downstream bottlenecks in mAb purification, reduce costs, and support process intensification from development to GMP scale.
Achieving cost-effective manufacturing while maintaining high quality standards today is one of the biggest challenges facing companies outsourcing mRNA/RNA development. In turn, panelists Qian Ruan, Andy Geall, and Alex Aust reflect on how and where they’ve seen the costs of mRNA-LNP manufacturing evolving/fluctuating in recent years.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Outsourcing RNA Feature Image]( "Outsourcing RNA-LNP Production: A Key To Competitive Success")
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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This study demonstrates an optimized cooling protocol for cryopreserving large-volume cryovials in a controlled-rate freezer, avoiding the need for liquid nitrogen.
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![Scientists In Laboratory GettyImages-1140779754]( "Future Proof Your Process Scale Workflow")
Discover how you can future-proof your process scale workflow, from starting bases to tangential flow filtration.
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![Oligonucleotide Manufacturing: Take Control Of Your Process]( "Oligonucleotide Manufacturing: Take Control Of Your Process")
What do you need to know before you take your process in-house? A team of experts on nucleic acids therapeutics outlined five key things for you to consider as you make the change.
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![LNP Formulations Feature]( "Fast Track RNA-LNP Drug Development By Lowering The Lipid Barrier")
Fast-track RNA-LNP development, streamline screening with off-the-shelf ionizable lipid mixes, and utilize validation strategies to generate reproducible and scalable LNPs for lead candidates.
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![GettyImages-523692032]( "Moderna's Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance")
The story of how Moderna brought one of the first mRNA vaccines to the market has all the makings of a legend we will pass down through generations. However, unlike the legends of King Arthur or The Fountain of Youth, we can celebrate that Moderna’s legendary journey was — and still is — real. Not only did the mRNA vaccines help return life to normal, but they also kickstarted the mRNA therapeutic renaissance we’re happily experiencing today.
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We are trying to simplify freezing and thawing protocols, basing them on biology and physics, and it is important to define these final steps to reduce wasting time, effort, and money. Delve into the science of cell thawing.
