MANUFACTURING ARTICLES
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![creativity, innovation-GettyImages-2209122228]( "Engineering RNA Agonists For Systemic Immunity Without Systemic Toxicity")
Engineering RNA Agonists For Systemic Immunity Without Systemic ToxicityKrieg believes the answer lies in a deeper understanding of innate immune biology and the design of RNA/DNA hybrid mimics of viral RNA and DNA that are detected by innate immune receptors.
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![economy law of supply and demand-GettyImages-1263079550]( "Is mRNA Manufacturing Overbuilt?")
Is mRNA Manufacturing Overbuilt?mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
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![Justified Risk-GettyImages-2232143649]( "What Oligo Manufacturing Risks Are We Underestimating?")
What Oligo Manufacturing Risks Are We Underestimating?Earlier this year, I attended the OPT Congress, where I had the great fortune of meeting consultant Marc Lemaitre. I recently sat down with Lemaitre for a follow-up interview to gauge some of the evolutions he’s been watching within the CMC landscape for oligo development. Here, he digs into the shifts in quality he’s noted, pointing out some of the potential pitfalls we may encounter in our manufacturing that could stand to impact the overall quality of our oligos.
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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.
MANUFACTURING VIDEOS
In this clip, Advancing RNA Live panelist Venkat Krishnamurthy unpacks how solid-phase synthesis has been improving to overcome current challenges with gRNA production, while Max De Long and April Sena share their perspectives on the maturity of current CDMO platforms for enzymatic ligation of gRNA.
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.
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.
The Mobius® MIX single-use mixing systems delivers advanced technology to make and purify plasmid DNA and mRNA.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Validate Cryopreservation As A Defined Input, Not A Variable")
Treating cryopreservation as a validated, controlled input improves consistency, quality, and patient outcomes by reducing variability across cell therapy manufacturing, storage, and distribution.
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![GettyImages-2158862132-vials-robotic-arm-filling-liquid-handling-lab]( "Aseptic Process Design And Simulation Under Annex 1 Guidelines")
Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.
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![mRNA iStock-1295693748]( "Efficient, Scalable Purification Of mRNA By Affinity Chromatography")
Increasing demand for mRNA as a therapeutic product requires efficient, scalable purification methods. Here, a monolithic stationary phase is used to purify mRNA from a capping mix of Luc2 RNA.
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![Operator loading nested vials into Microcell vial filler]( "CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics")
CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.
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![GettyImages-1076055404 chromatography, purification]( "The Secret To Pure Oligos: Why Anion Exchange Chromatography Rules At Scale")
Discover how anion exchange chromatography delivers high loading capacity and clinical-grade purity while addressing common scale-up challenges like aggregation and equipment longevity.
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![GettyImages-1355122387 RNA]( "Improvement Of Self-Amplifying RNA Quality And Potency With IVT Optimization")
Explore our study on optimizing In-Vitro Transcription (IVT) conditions for self-amplifying RNAs to achieve high yields, low residual dsRNA, and improved potency, and learn how these advancements can enhance RNA-based therapies.
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![GettyImages-1293772880-Lab-Science-Research-Scientist-Discovery-Development]( "From Data To Decisions: Accelerating Your mRNA Drug Development With Analytics")
To stay ahead in the competitive landscape of mRNA development, adopt a comprehensive QC strategy today and begin conducting meaningful tests to ensure the quality of your test articles.
