MANUFACTURING ARTICLES
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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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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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RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation
From 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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What Baby KJ Taught Us About mRNA COGS
Here, 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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Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics
RNA 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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A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products
NIST 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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Transitioning from fresh to frozen starting material stabilizes cell therapy inputs, but isolated workflows introduce risk. Integrated logistics safeguard quality as trial footprints expand.
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Explore each intertwined step in the mRNA manufacturing process and how a flexible approach can get your mRNA product to clinic and market faster.
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Clarifying post–virus inactivation streams with a charged depth filter can remove precipitates while significantly reducing HCPs. See how a dual‑layer filtration approach supports stronger impurity control.
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Reach new heights in mAb production with a high-intensity perfusion CHO medium designed to support consistently high product yield and quality in continuous perfusion cultures using CHO-K1 cells.
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This article explores the details of Chemistry, Manufacturing, and Controls and Critical Quality Attributes, which play an important role in gene editing.
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Get a clear, data-driven look at the biggest pressure points in cell therapy manufacturing. Explore the trends shaping today’s production challenges and where new opportunities are emerging.
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Gain insight into the modest origins of cell therapy manufacturing and how this history has paved the way for future advancements from Bill Shingleton, R&D Leader at Cytiva.