MANUFACTURING ARTICLES
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![economy law of supply and demand-GettyImages-1263079550]( "Is mRNA Manufacturing Overbuilt?")
Is mRNA Manufacturing Overbuilt?mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
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![Justified Risk-GettyImages-2232143649]( "What Oligo Manufacturing Risks Are We Underestimating?")
What Oligo Manufacturing Risks Are We Underestimating?Earlier this year, I attended the OPT Congress, where I had the great fortune of meeting consultant Marc Lemaitre. I recently sat down with Lemaitre for a follow-up interview to gauge some of the evolutions he’s been watching within the CMC landscape for oligo development. Here, he digs into the shifts in quality he’s noted, pointing out some of the potential pitfalls we may encounter in our manufacturing that could stand to impact the overall quality of our oligos.
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![DNA Structure with molecule-GettyImages-2199475157]( "RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation")
RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating InnovationFrom a tech perspective, the manufacturing objective is shifting toward integrated process optimization. Automated reaction control, multivariate analytics, and more can connect molecular quality with operational performance.
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![money loss, spending, poor financial management-GettyImages-2224880481]( "What Baby KJ Taught Us About mRNA COGS")
What Baby KJ Taught Us About mRNA COGSHere, in part 2 of this three-part series, I share a few details that came to light about the COGS behind Baby KJ’s therapy production. Obviously, we know why it’s important to keep these figures in mind as we move forward; but I particularly liked Strauss’ reminder that it’s our job to “think systematically about how we’re going to create a safety net of sustainable, accessible product that can be widely distributed at an affordable cost.”
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![intelligent technology interface, robot chat-GettyImages-2279572840]( "Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics")
Analytical Platforms: The Foundation Of The Next Generation Of RNA TherapeuticsRNA therapeutics are entering a new era where analytical platforms drive scalability, regulatory confidence, manufacturing flexibility, and the development of increasingly complex products.
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![nucleic acid, DNA, RNA, purified protein-GettyImages-1350828873]( "A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products")
A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA ProductsNIST research introduces a gentle SEC method that separates dsRNA impurities from IVT mRNA by tweaking buffer pH, achieving 81.8% target recovery without transcript damage.
MANUFACTURING VIDEOS
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.
Learn how flexible approaches can help address the considerations and hurdles in mRNA manufacturing.
Advancing RNA Live panelists identify what is “as good as we can get right now” in terms of understanding our IVT reactions while sharing their ideas on how we can arrive at a future that includes real-time monitoring of our drug substance production processes.
Experts from this Advancing RNA Live panel discuss the results from a poll question revealing the top three areas RNA industry experts would be most interested in seeing additional mRNA-specific guidance from regulatory agencies.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Car-T cell attacking cancer cell-GettyImages-2252478724]( "Automated Cryo‑Processed Leukapheresis For CAR‑T Manufacturing")
Automated, closed cryo‑processing of leukapheresis preserves cell quality and functionality, enabling flexible, reproducible starting material for both autologous and allogeneic CAR‑T manufacturing.
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![GettyImages-1354923731-magnifying-glass-mrna]( "Best Practices For Analysis Of In Vitro Transcribed (IVT) mRNA")
Learn best practices for high-resolution analysis of IVT RNA using automated capillary electrophoresis. Improve accuracy and precision in quantifying critical quality attributes.
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![Why You Need Spare Parts On Hand For Pharma And Lab Equipment]( "Why You Need Spare Parts On Hand For Pharma And Lab Equipment")
Advanced spare parts planning can reduce downtime. Learn why precise component specifications matter and how seemingly identical parts can differ significantly in quality, performance, and failure risk.
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![GettyImages-1622519985 cryopreservation, cold chain]( "Standardization Where It Matters Most")
Freezing doesn’t ensure consistency. Standardized cryopreservation removes site‑to‑site variability, providing predictable starting materials and lowering scientific and operational risk.
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![GettyImages-525440891-lab-research-development]( "Avoiding The Pitfalls Of LNPs And Complex Formulations")
Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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![GettyImages-1326811027-lab]( "New To mRNA Manufacturing? Considerations For Starting")
Explore considerations for starting mRNA manufacturing related to the following topics: DNA template, mRNA product - IVT, mRNA product - purification, LNP encapsulation, and fill-finish.
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Here, a fast and efficient way to purify polyadenylated mRNA using affinity chromatography on the CIMmultus® Oligo dT column is presented.
