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
Explore critical steps and key regulatory requirements for developing CRISPR therapeutics and gain practical advice on how to avoid common pitfalls.
As the panelists of this Advancing RNA LIVE discussion argue, there are several big limitations we face in implementing QBD today for RNA development.
This Tea Time Webinar is presented by Dr. Ruth Schmid, Vice President Marketing at SINTEF in Trondheim, Norway, with a special responsibility for the field of medical technology, including nanomedicine at SINTEF.
mRNA-based therapeutics require comprehensive analytical testing to meet regulatory requirements. Optimize processes and ensure fast and reliable results as you bring your product to market.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Software Analytics]( "Bio4C ProcessPad™ 21 CFR Part 11 Compliance")
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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![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.
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![GettyImages-1298788278 drug manufacturing]( "Improving U.S. Drug Supply Stability Through Continuous Nanoparticle Processing")
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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![GettyImages-2148124393 DNA]( "A Risk-Based Approach To Plasmid DNA And mRNA Process Development")
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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![GettyImages- 1180547354 trial data]( "Understanding CRISPR Clinical Trials: Your Questions Answered")
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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![GettyImages-1026593952 tablet, data]( "Difco TC Yeastolate Ultra-Filtered (TCY UF) In Scale-Up Optimization")
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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![risk]( "Aseptic Process Sampling Risk Mitigation – A Regulatory Perspective")
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.
