MANUFACTURING ARTICLES
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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.
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![Scattered thoughts-GettyImages-2178092695]( "The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational Friction")
The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational FrictionScientific breakthroughs may spark innovation, but operational excellence ultimately determines which advanced therapies reach patients.
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![DNA target nanodrugs-GettyImages-1405926704]( "RNA Therapeutics: Why CMC Strategy Will Define The Next Decade")
RNA Therapeutics: Why CMC Strategy Will Define The Next DecadeAs 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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![AI Medical Technology-GettyImages-2242544252]( "Rethinking The Oligonucleotide Backbone: Why RNA Therapeutics May Need A New Molecular Design Framework")
Rethinking The Oligonucleotide Backbone: Why RNA Therapeutics May Need A New Molecular Design FrameworkNew backbone chemistries could unlock greater control over delivery, specificity, and safety, expanding the molecular design space for RNA medicines.
MANUFACTURING VIDEOS
The clinical promise of mRNA therapeutics and vaccines is clear, but compared to monoclonal antibodies or viral vectors, their novelty also brings new challenges to the manufacturing process.
Walk step-by-step instructions through how you can set up the Nova Benchtop System and make your first LNPs.
Introducing Bio4C ProcessPad™ Software, part of the BioContinuum™ Platform.
Built on our revolutionary NxGen™ technology found in our NanoAssemblr® family of instruments, NanoAssemblr® GMP System enables you to go from concept to clinic with speed and confidence.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-909908830]( "Navigating The Regulatory Maze: Fundamentals For Drug Development")
Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey.
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![Quality-GettyImages-1360733079]( "Understanding The Hidden Value Of Quality")
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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![GettyImages-2158862132-vials-robotic-arm-filling-liquid-handling-lab]( "Aseptic Process Design And Simulation Under Annex 1 Guidelines")
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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![GettyImages-1070902452-planning-tracking-packaging-shipment]( "Setting The Benchmark For Quality In Cell And Gene Therapy Logistics")
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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![Precision NanoSystems Feature]( "Understanding The Microfluidic Platforms For Scaling Nanoparticle Production")
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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![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Validate Cryopreservation As A Defined Input, Not A Variable")
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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![GettyImages-970394878-genetic-engineering-gene-editing-dna]( "Genome Editing Using mRNA-Lipid Nanoparticles For CAR T Cell Therapy")
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.
