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
In this Bioprocess Online Live panel, we discuss two experts' perspectives on the current state of the mRNA supply chain for critical raw materials and manufacturing supplies and where pain points still exist.
BioNTech’s Ben Muir shares a high-level overview of the LNP preclinical research advances that are the most exciting/promising today — while also reminding us of a few important caveats that accompany early-stage research.
Unlock the power of data-driven bioprocessing. Discover how advanced analytics can optimize your cell culture process, improve performance, and accelerate success.
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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![mRNA GettyImages-1356994684]( "mRNA Manufacturing And Formulation")
From fermentation to formulation, mRNA manufacturing requires a toolbox of technologies, services, and expertise. Explore our portfolio of solutions for making, purifying, and formulating mRNA.
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![mammlian-cell-lines-GettyImages-1690936576]( "FDA's New Flexible CMC Framework For CGT")
The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.
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![MilliporeSigma]( "Next-Gen Bioprocess Monitoring: Smart Data Management And Analysis")
A new platform that includes digital technologies/data management, process analytical technologies and intensified processing will drive next generation bioprocessing.
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![Aseptic Filling]( "Addressing The Challenges Of Late-Stage Aseptic Manufacturing")
Gain insight into the current landscape of filling and late-stage manufacturing from a survey of 78 professionals from top companies in the industry.
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![GettyImages-2017789595 lab, research]( "Essential Strategies For IVT Optimization")
Optimizing in vitro transcription (IVT) for mRNA is crucial to improving the stability of these molecules and enabling their large-scale production.
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![GettyImages-1297146235-dna]( "Review Of mRNA Vaccines & Therapeutics Manufacturing Challenges: Plasmid DNA Manufacturing")
This review suggests technical remedial options for the production of pDNA and focuses on mRNA synthesis, purification, and encapsulation.
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![lab virtual science biologic bioprocess 450x300]( "5 Biggest Trends Of Oligonucleotide Manufacturing In 2022")
The rapidly growing market for Oligonucleotide manufacturing represents an opportunity for investors and pharma companies that wish to produce novel pharmaceutical products and therapies.
