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
As the panelists of this Advancing RNA LIVE discussion argue, there are several big limitations we face in implementing QBD today for RNA development.
With benefits across applications, nanoplasmids are designed to replace antiquated bacterial backbones, while eliminating antibiotic markers that can cause regulatory concerns.
What is Bio-Layer Interferometry (BLI)? Watch to learn about BLI and the advantages of utilizing a proven BLI platform.
In this Bioprocess Online Live panel discussion, experts share the most important factors to consider when assessing the manufacturability of novel linear mRNA candidates in order to bring forward the most successful lead candidates.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![lab virtual science biologic bioprocess 450x300]( "5 Biggest Trends Of Oligonucleotide Manufacturing In 2022")
The rapidly growing market for Oligonucleotide manufacturing represents an opportunity for investors and pharma companies that wish to produce novel pharmaceutical products and therapies.
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![GettyImages-1288118586 cell development]( "The Future Is Now: CGT Innovation, Challenges, And Perspectives")
As CGTs advance toward clinical trials, developers face a number of challenges such as navigating a shifting regulatory landscape and employing beneficial manufacturing processes.
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![GettyImages-525440891-lab-research-development]( "Avoiding The Pitfalls Of LNPs And Complex Formulations")
Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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Using its Supplier Relationship Excellence program, Amgen opened the lines of communication with suppliers and created a feedback loop where data can be shared to optimize operational performance.
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The concept of optionality is key to staying flexible in biomanufacturing by keeping your options open and having multiple pathways to take while navigating through this highly uncertain environment.
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![Gene Therapy GettyImages-1164556175]( "mRNA Product IVT Process Insights")
In vitro transcription (IVT) allows a researcher to tailor synthesis and introduce modifications to produce a transcript. Learn about IVT along with process challenges and strategies.
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![DNA molecules 450x300]( "Chromatographic Purification Of Plasmid DNA")
Widespread application of pDNA in gene therapy is driving increased demand and as a response, plasmid manufacturing must become more efficient with improved productivity. Intensification of chromatographic steps can help address this demand and has led to an exploration of the use of convective media (monoliths, membranes, fibre based technologies).
