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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A lack of standardization and cost-effective techniques for manufacturing and analytics for product characterization create CMC challenges for mRNA-based products.
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Costs of poor quality (COPQ) cannot be overstated. Review the statistics that prove how costly it can be to avoid resolving quality issues in your processes and supply chain.
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Whether prioritizing mass spectrometry compatibility or loading capacity, understanding the specific trade-offs between IP-RP, AEX, and SEC methodologies is essential for successful characterization.
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The promise of novel therapeutic modalities can only be realized when effective science is paired with efficient manufacturing to provide cost-effective therapies to patients in need.
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Learn more about the challenges that arise during the synthesis, purification, and encapsulation of mRNA.
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Take a step-by-step review of the mRNA therapeutics journey and find out how you can meet the critical process, scale, quality and regulatory needs from development to commercialization.
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mRNA has the potential to revolutionize the field of vaccine development. However, it is critical we understand any factors that could impact its successful entry into today’s market.