MANUFACTURING ARTICLES
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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.
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![Virology, infectious diseases, virus diagnostics, virus research, biotechnology-GettyImages-2219621039]( "RNA Platforms: What Transfers And What Breaks")
RNA Platforms: What Transfers And What BreaksA practical framework for distinguishing reusable RNA platform knowledge from biology-specific unknowns as therapeutics expand into new tissues and indications.
MANUFACTURING VIDEOS
Chief Scientific Officer and Founder Christian Cobaugh, Ph.D., examines the critical quality attributes of mRNA and LNPs that are pivotal to enhancing drug efficacy and safety.
Advancing RNA Live panelists Venkat Krishnamurthy, April Sena, and Max De Long share their perspectives on the most important regulatory considerations for gRNA production utilizing an enzymatic ligation approach.
While we can make lots of mRNA at a smaller scale, when it comes to scaling up to kg quantities of mRNA, our current batch processes leave a lot to be desired. Together, Stu Sundseth of Tune Therapeutics and Christian Dohmen of Ethris unpack the biggest barriers to scaling IVT to achieve the desired yield and quality of mRNA, offering their take on how the field is innovating to overcome these issues.
In this snippet, panelist Alex Aust (with the help of several live attendee commenters) tackles a particularly tricky question: Are our outsourcing partnerships producing high quality products today, and what are the most common root causes of batch failures?
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-139602926 labeling, packaging, pharma]( "What Is ISO 21973 And Why It Matters For Cell And Gene Therapy")
ISO 21973 establishes global best practices for transporting cell and gene therapies, ensuring quality, safety, and consistency across complex supply chains critical to patient outcomes.
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![RNA abbreviation of ribonucleic acid-GettyImages-1453953422]( "Navigating Challenges In Progressing Breakthrough RNA Therapeutics")
RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.
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![mRNA GettyImages-1356994684]( "Elevating mRNA Manufacturing Toward GMP-Readiness")
The mRNA Technology Transfer Program empowers LMICs with scalable vaccine production. Learn about a partnership that drives innovation in mRNA and sets a global blueprint for equitable health access.
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![1100x600 real ebook image Cytiva white background]( "Aseptic Filling By Design: Shaping The Future Of Drug Manufacturing")
Modern therapies demand higher sterility assurance and flexible operations. Discover how advanced contamination control, barrier systems, and automation strengthen quality and support faster delivery.
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![GettyImages-1751659695-laboratory-scientists-computer-analysis-evaluation]( "Driving Global ATMP Logistics Through Cold Chain Innovation")
Examine how a centralized logistics hub can transform the distribution of ATMPs, ensuring that sensitive therapies reach patients safely and efficiently.
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![Cryoport Systems New Facilites 03.06.2023]( "Cryoport Systems Global Supply Chain Center: Ready For Launch!")
Cell & gene therapies are rapidly outpacing the industry's limited manufacturing capacity. Learn more about the developing network of supply chain centers built to support this growing client base.
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![GettyImages-2193391345-cryopreservation]( "How Operational Efficiency Shapes Late-Phase Manufacturability")
Prioritize operational efficiency over early-stage flexibility to scale advanced therapies. Standardized workflows and qualified shipping lanes reduce variability for predictable late-phase success.
