MANUFACTURING ARTICLES
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![AI, artificial intelligence, dna research-GettyImages-2192601384]( "Bridging The Atlantic: A European Executive's Guide To Entering The U.S. RNA Market (Pt. 1)")
Bridging The Atlantic: A European Executive's Guide To Entering The U.S. RNA Market (Pt. 1)A practical roadmap for European biotech leaders navigating FDA expectations, market entry, and the strategic decisions that shape U.S. expansion.
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![DNA holographic floating at lab Salubrious-GettyImages-2221232296]( "Patenting RNA Therapeutics In The Age Of AI: What Companies Must Get Right Early")
Patenting RNA Therapeutics In The Age Of AI: What Companies Must Get Right EarlyAs AI transforms RNA discovery, companies must rethink inventorship, obviousness, and patent strategy to secure durable intellectual property protection.
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![Mechanism of Antibody-oligonucleotide conjugates or AOC-GettyImages-1826415391]( "Understanding Therapeutic Oligonucleotide Purification By Anion Exchange Chromatography: From Resin Architecture To Process Productivity")
Understanding Therapeutic Oligonucleotide Purification By Anion Exchange Chromatography: From Resin Architecture To Process ProductivityExplore how anion exchange chromatography improves oligonucleotide purification through smarter resin design, better separation, and scalable manufacturing.
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![Production line of vaccine vials automated by robotic arms-GettyImages-1462345800]( "The Future Of RNA Manufacturing: Continuous Processing, AI, And Distributed Production (Pt. 3)")
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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![GettyImages-165748654]( "Can Oligonucleotide Regulations Keep Up With Manufacturing Innovation?")
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 a mystery-GettyImages-173547527]( "Unlocking The Future Of mRNA")
Unlocking The Future Of mRNAMany 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.
MANUFACTURING VIDEOS
While the speed of production and flexibility of mRNA are appealing, several industry challenges must still be addressed to realize the full potential and further expand its use.
Three regulatory experts share the topics on which they hope to see further agency clarification in the near-term to help mRNA products make meaningful progress toward/through the clinic.
Developing a client-sponsored Target Product Profile (TPP) and Analytical Target Profile (ATP) is critical to move your drug product to clinic efficiently and meet acceptance criteria.
Hosted by Cell & Gene Collaborative Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 5, Welch dives into the separate — but strikingly similar — worlds of fly fishing and mRNA R&D. In particular, she explains how a fly fisherman’s strategies to catch a fish relate to the work of mRNA scientists as they strive to identify the most appropriate immunogenicity profiles for their mRNA vaccines or therapeutics.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Scientists laboratory pipette GettyImages-621351044]( "Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs")
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
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![Outsourcing RNA Feature Image]( "Outsourcing RNA-LNP Production: A Key To Competitive Success")
Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.
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![GettyImages-1213899382-electrophoresis-pipette-cell-loading]( "Quality Control In IVT RNA Workflow")
Accurate sizing and purity checks are essential in IVT RNA workflows. Explore how automated electrophoresis improves QC efficiency and ensures RNA integrity for downstream applications.
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![GettyImages-1357908552-rna-ribonucleic-acid]( "Expand Your Toolbox For Quality mRNA Manufacturing")
Explore guidelines for the use of SP6 RNA Polymerase in mRNA synthesis and your mRNA production processes.
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![GettyImages-2151198847-lipid-nanoparticle-with-rna-strands]( "Advancing Cell Therapies With Lipid Nanoparticles")
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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![Feature Image 1]( "mRNA Product Purification Process Strategies")
Impurities from IVT can induce undesired immune responses and negatively impact translation efficiency. Explore the pros and cons of each option for mRNA purification.
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![GettyImages-1135140461-lab-team]( "Imagine The Future: Enhanced Oligonucleotide Synthesis")
Learn about flexible control software that has revolutionized the way method creation, evaluation, and process optimizations for scale-up are completed.
