MANUFACTURING ARTICLES
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The Future Of RNA Manufacturing: Continuous Processing, AI, And Distributed Production (Pt. 3)
Continuous manufacturing, AI, modular facilities, and next-generation RNA platforms are reshaping how therapies are produced, scaled, and delivered worldwide.
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Can Oligonucleotide Regulations Keep Up With Manufacturing Innovation?
Here in part 2 of my TIDES takeaways, I’ll unpack which guidances we have at our disposal today in the oligo world, and what we can expect in the future.
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Unlocking The Future Of mRNA
Many regulatory frameworks and analytical approaches were not originally designed for platforms like mRNA. Addressing these gaps will be essential to fully realize the potential of mRNA technologies.
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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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey.
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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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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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ISO 21973 defines global best practices for transporting cell and gene therapies, ensuring safety, quality, and consistency across complex supply chains vital to patient care.
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Learn about the benefits of microfluidics for nanoparticle production over traditional methods as well as scaling nanoparticle production for clinical or industrial use.
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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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Gene delivery platforms must support a diversity of genetic engineering strategies for genomic medicine development. Learn how lipid nanoparticles can accelerate development from discovery to scale-up.