MANUFACTURING ARTICLES
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RNA Therapeutics: Why CMC Strategy Will Define The Next Decade
As RNA matures into an industrial platform, long-term success will depend less on discovery and more on scalable CMC systems, integration, and execution.
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Rethinking The Oligonucleotide Backbone: Why RNA Therapeutics May Need A New Molecular Design Framework
New backbone chemistries could unlock greater control over delivery, specificity, and safety, expanding the molecular design space for RNA medicines.
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RNA Platforms: What Transfers And What Breaks
A practical framework for distinguishing reusable RNA platform knowledge from biology-specific unknowns as therapeutics expand into new tissues and indications.
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Stay "Stereocurious": What The Future Holds For Oligo Quality
Overall, there were two areas of discussion at TIDES that demonstrate the amount of growth we have yet to do as a space — particularly in the realms of regulatory development and quality. As I intend to showcase here in part 1 of this muti-part article, this year’s TIDES was a great reflection of the tension(s) that can arise as we realize how much space exists between where we are and where we’re going next.
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Scaling RNA Therapeutics: Purification, LNP Formulation, And GMP Manufacturing (Pt. 2)
Part 2 explores the downstream technologies that turn RNA into a therapeutic product, from impurity removal and LNP formulation to GMP infrastructure and scalable manufacturing.
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What Makes An RNA Platform Investable? Lessons From The Last Wave Of Biotech Financing
RNA investing has shifted from hype to scalability, forcing companies to prove manufacturability, delivery strength, and platform-wide value.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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).
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An outbreak of mycoplasma can halt a biopharmaceutical facility's production for months. Explore the impact of mycoplasma contamination and the most accurate and sensitive way to detect it.
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Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.
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With so many uncertainties permeating the mRNA market, this largely preclinical industry is still seeking answers on how to reach successful therapeutic development. Identifying optimizations, both sequence-dependent and otherwise, to enhance the manufacturing process is crucial for advancing mRNA product development, which holds vast potential to address a wide range of indications.
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Cell therapies, using reprogrammed immune cells, offer innovative treatments for diseases. Discover how lipid nanoparticles (LNPs) enhance these therapies by delivering RNA for gene modulation and next-gen treatments.
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Here, a fast and efficient way to purify polyadenylated mRNA using affinity chromatography on the CIMmultus® Oligo dT column is presented.
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Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.