MANUFACTURING ARTICLES
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![DNA Structure with molecule-GettyImages-2199475157]( "RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation")
RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating InnovationFrom a tech perspective, the manufacturing objective is shifting toward integrated process optimization. Automated reaction control, multivariate analytics, and more can connect molecular quality with operational performance.
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![money loss, spending, poor financial management-GettyImages-2224880481]( "What Baby KJ Taught Us About mRNA COGS")
What Baby KJ Taught Us About mRNA COGSHere, in part 2 of this three-part series, I share a few details that came to light about the COGS behind Baby KJ’s therapy production. Obviously, we know why it’s important to keep these figures in mind as we move forward; but I particularly liked Strauss’ reminder that it’s our job to “think systematically about how we’re going to create a safety net of sustainable, accessible product that can be widely distributed at an affordable cost.”
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![intelligent technology interface, robot chat-GettyImages-2279572840]( "Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics")
Analytical Platforms: The Foundation Of The Next Generation Of RNA TherapeuticsRNA therapeutics are entering a new era where analytical platforms drive scalability, regulatory confidence, manufacturing flexibility, and the development of increasingly complex products.
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![nucleic acid, DNA, RNA, purified protein-GettyImages-1350828873]( "A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products")
A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA ProductsNIST research introduces a gentle SEC method that separates dsRNA impurities from IVT mRNA by tweaking buffer pH, achieving 81.8% target recovery without transcript damage.
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![Leukodystrophy Awareness Month-GettyImages-2166836167]( "The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)")
The Preclinical Gauntlet: Securing Capital And Designing Regulatory Pathways For Ultra-Rare ASO Drugs (Pt. 2)SynaptixBio CEO Dan Williams explains why funding, regulatory strategy, toxicology, and disciplined execution — not just science — determine success in advancing ultra-rare ASO therapies.
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![MacKay suspension bridge-GettyImages-2281791194]( "Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)")
Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)European RNA biotech leaders can accelerate U.S. success by aligning fundraising, partnerships, manufacturing, hiring, and regulatory strategy from day one.
MANUFACTURING VIDEOS
In this segment of a recent Bioprocess Online Live! panel discussion, Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus address a rapid cadence of audience questions.
In this segment from the Surge Manufacturing for Biopharma Resilience live event, University of Sheffield’s Dr. Zoltán Kis shares the work he’s doing on the Wellcome Leap RNA R3 program.
Compare sterilizing-grade membrane performance at high and low pressures, including throughput, bacterial retention, and the effects of filtration on particle diameter and encapsulation efficiency.
See how reducing secondary interactions in size exclusion chromatography gives scientists greater freedom to optimize conditions around their samples, helping simplify method development.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1087219020 Scientists wearing protective coveralls working in manufacturing laboratory]( "Insights Into GMP Manufacturing Of RNA-LNP Drug Products")
Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.
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![GettyImages-1307980860-dna-rna-vial-gene]( "Optimizing Lipid Formulations For Targeted RNA-LNP Applications")
Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.
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![data-clinicial-GettyImages-2185301670]( "Why Your Bioanalysis Bottleneck Is Costing You More Than You Think")
This piece explains why turnaround time is a strategic variable, where speed is truly achievable, and how automation reshapes the path from sample submission to decision‑ready data.
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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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![GettyImages-139602926 labeling, packaging, pharma]( "What Is ISO 21973 And Why It Matters For Cell And Gene Therapy")
ISO 21973 establishes global best practices for transporting cell and gene therapies, ensuring quality, safety, and consistency across complex supply chains critical to patient outcomes.
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![GettyImages-1295693748-mRNA]( "Addressing Challenges In mRNA Drug Development And Manufacturing")
mRNA-based drug products serve as an ideal platform for use in infectious disease, protein replacement, and immuno-oncology applications due to the simplicity of manufacturing and robust immune response.
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![Virus and Genes iStock-843037718]( "Downstream Process For Gene Therapy, Plasmid-DNA Vaccine Development")
A guide to plasmid DNA downstream process development including clarification, TFF, chromatography, and sterile filtration unit operations.
