MANUFACTURING ARTICLES
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The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational Friction
Scientific breakthroughs may spark innovation, but operational excellence ultimately determines which advanced therapies reach patients.
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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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Aseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.
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The benefits of continuous flow manufacturing are significant and numerous and those benefits grow with each technological breakthrough and methodological advance.
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To keep up with oligonucleotide demand, manufacturing needs to shift toward larger-scale processes, but this scale-up process brings challenges that must be addressed.
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Automated capillary electrophoresis provides robust, precise analysis of IVT mRNA integrity, concentration, and size, demonstrating excellent method precision.
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Explore the advantages of paperless manufacturing, the importance of incorporating a digital strategy early in the process, and how digital solutions for mRNA manufacturing can help enhance production.
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Understanding how to fine-tune pH and ionic strength allows for the detection of truncated sequences and single-nucleotide variants, turning complex purification challenges into reproducible data.
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Explore the automated production of protein microparticles using an innovative method that offers a standardized and scalable solution for co-precipitation in biopolymer particle fabrication.