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 how Bio4C ProcessPad™ meets 21 CFR Part 11 requirements including unique usernames and passwords, timestamped audit trails, and secure storage of all records.
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Learn about flexible control software that has revolutionized the way method creation, evaluation, and process optimizations for scale-up are completed.
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Learn about a continuous manufacturing platform designed to help overcome challenges in domestic pharmaceutical production, including scale-up barriers and production variability.
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Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
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CRISPR technology is revolutionizing cell and gene therapies, but how do CRISPR clinical trials work? Follow this explanation of CRISPR therapies from the discovery phase to FDA approval.
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Explore how Difco™ TC Yeastolate ultra-filtered (TCY UF) enabled over 100% improvement in titer for CHO cell culture through feed optimization and bioreactor scalability in a real-world application.
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This overview outlines regulatory guidelines for sampling, examines the limitations of conventional methods, and emphasizes the advantages of aseptic, single-use approaches in achieving compliance.