MANUFACTURING ARTICLES
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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.
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![Burrowing owl-GettyImages-964611070]( "Stay \"Stereocurious\": What The Future Holds For Oligo Quality")
Stay "Stereocurious": What The Future Holds For Oligo QualityOverall, there were two areas of discussion at TIDES that demonstrate the amount of growth we have yet to do as a space — particularly in the realms of regulatory development and quality. As I intend to showcase here in part 1 of this muti-part article, this year’s TIDES was a great reflection of the tension(s) that can arise as we realize how much space exists between where we are and where we’re going next.
MANUFACTURING VIDEOS
Learn about a complete purification process flow that overcomes the challenges of producing pDNA – a critical first step in mRNA manufacturing – and covers all downstream unit operations.
Discover how speed, cost, and regulatory acceptance impact drug manufacturing, as well as learn about aseptic filling challenges and how innovative services can enhance your efficiency and compliance.
Master the essential strategies for cost-effective and robust mRNA capping at industrial scale. Learn how to successfully evaluate new materials and optimize your synthesis process for maximum efficiency and yield.
Learn about method development considerations when selecting an appropriate ion-pairing agent and impurity analysis of dye-conjugated oligonucleotides.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1325865279-patient-doctor]( "5 Things We Need To Do To Improve The US Healthcare System")
Mark Sawicki, Ph.D, Chief Executive Officer at Cryoport Systems, shares his perspective of the current state of the healthcare system, what areas can be improved, and specific steps to achieve the change.
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![GettyImages-1319439243-dna-gene-therapy-helix]( "Genomic Medicine Demands Manufacturing Innovation")
The promise of novel therapeutic modalities can only be realized when effective science is paired with efficient manufacturing to provide cost-effective therapies to patients in need.
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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-1356994684-epigenetics-rna]( "Understanding mRNA Technology As A Platform For Biopharma")
Explore the advantages of mRNA technology, the process steps of large-scale mRNA production, and the effect of common contaminants on mRNA manufacturing.
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![Doctor Preparing Injection Site GettyImages-1379313214]( "How LNP Technology Meets The Delivery Need Of saRNA Vaccines")
Explore challenges to the successful development of RNA-based drugs and vaccines as well as the advantages of utilizing lipid nanoparticle technology as a delivery platform for saRNA.
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![mRNA GettyImages-1428646288]( "Advanced Therapies Going Mainstream: Are We There Yet?")
Advanced therapies are nearing mainstream adoption, with cell, mRNA, and oligonucleotide treatments expanding into broader indications. Learn what’s driving this shift and what manufacturers must do.
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![AM STABTEST Waters Inc]( "A&M STABTEST Expands Service Offerings In Protein And Oligonucleotide Analysis With LC-MS System")
CRO upgrades systems to provide regulatory compliance for large-molecule protein analysis, expanding their oligonucleotides capabilities.
