MANUFACTURING ARTICLES
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![Future-GettyImages-834713748]( "Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future Directions")
Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future DirectionsThis last article of the author's series on AOCs reveals regulatory perspective, analytical opportunities, the emergence of molecular quality by design, and the CMC challenges to address with future work.
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![Action Plan-GettyImages-2249288072]( "Antibody–Oligonucleotide Conjugates, Part 2: Manufacturing")
Antibody–Oligonucleotide Conjugates, Part 2: ManufacturingLet's delve into manufacturing strategy, conjugation chemistry, process development and scale-up, and purification: the central manufacturing challenge.
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![Financial security, wealth protection, money insurance-GettyImages-2288391875]( "Protecting The Platform: Trade Secret Protection For RNA Biotech Companies")
Protecting The Platform: Trade Secret Protection For RNA Biotech CompaniesAs RNA therapeutics grow more complex and collaborative, trade secrets are becoming an increasingly important part of protecting valuable platform innovation.
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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.
MANUFACTURING VIDEOS
Experts from this Advancing RNA Live panel discuss the results from a poll question revealing the top three areas RNA industry experts would be most interested in seeing additional mRNA-specific guidance from regulatory agencies.
Join pDNA and mRNA specialists as they discuss innovative mRNA manufacturing solutions for your purification challenges, mRNA stability, and overall product quality.
Discover key upstream and downstream considerations for process development for RNA drug substance manufacturing and the parameters that need construct-specific optimization to increase yield and reduce impurities.
Examine why template sequence characteristics are relevant for cGMP manufacturing of high-quality mRNA and consider insights on how to develop a scalable, robust, and economically viable process.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1354923731-magnifying-glass-mrna]( "Best Practices For Analysis Of In Vitro Transcribed (IVT) mRNA")
Learn best practices for high-resolution analysis of IVT RNA using automated capillary electrophoresis. Improve accuracy and precision in quantifying critical quality attributes.
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![Lipid Nanoparticles GettyImages-1437855772]( "How Lipid Nanoparticles Enable Next-Gen Delivery")
Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.
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![injecting vaccine vaccination-GettyImages-665515600]( "21st Century Manufacturing Of Injectable Pharmaceuticals")
Discover how rising competition, niche patient populations, and evolving therapies are reshaping sterile injectable drug development with cutting-edge technologies.
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![iStock-1208824917-molecule-structure]( "Metabolite ID And Relative Quantification Of Oligonucleotides In Plasma")
This technical note describes the identification, relative quantification, and structural confirmation of the chain-shortened metabolites of a phosphorothioated oligonucleotide.
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![GettyImages-1368058797 vial, fill finish]( "Key Topics And Trends In Aseptic Filling")
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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![GettyImages-1295693748-mRNA-strand]( "Characterizing mRNA Using Ion-Pairing Reversed-Phase LC/MS")
mRNA poly(A) tail analysis depends on targeted digestion, clean LC/MS conditions, and reliable deconvolution. See how RNase 4 digestion and optimized ion-pairing methods support reproducible results.
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![iStock-1293772874-lab-plasmid-gene therapy-DNA]( "Residual Plasmid Quantification In Gene Therapy Manufacturing Workflows")
This article details the design and application of a Plasmid DNA - Kanamycin Resistance Gene (pDNA-KanR) kit for residual plasmid quantification in gene therapy manufacturing.
