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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Gain insight into the recent advancements in connectivity and integration technology, the associated challenges, and the importance of a vendor-neutral approach.
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Methodologies from a distribution standpoint had to be redeveloped to be significantly more rigorous, eliminating those allowances for time out of environment (TOE) and similar criteria.
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Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.
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Learn how purpose-driven decisions backed by a thorough process that reaps you the largest profit potential over time can result in successful scale up.
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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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Learn how optimizing LNPs can help overcome drug-delivery challenges, unlocking potential new genomic medicines in a shorter time.
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How a multi-capillary electrophoresis (CE) system is used to efficiently separate a wide range of RNA-based molecules by size and demonstrates the multiplex capability for RNA characterization.