MANUFACTURING ARTICLES
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Protecting The Platform: Trade Secret Protection For RNA Biotech Companies
As RNA therapeutics grow more complex and collaborative, trade secrets are becoming an increasingly important part of protecting valuable platform innovation.
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Engineering RNA Agonists For Systemic Immunity Without Systemic Toxicity
Krieg believes the answer lies in a deeper understanding of innate immune biology and the design of RNA/DNA hybrid mimics of viral RNA and DNA that are detected by innate immune receptors.
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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.”
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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As CGTs advance toward clinical trials, developers face a number of challenges such as navigating a shifting regulatory landscape and employing beneficial manufacturing processes.
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Explore an automated, compliance-ready LC-MS workflow for intact mass confirmation and purity analysis of synthetic oligonucleotides including siRNA and large single guide RNA oligonucleotides.
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There are two key challenges to realizing the potential of genomic medicines, but potential technological solutions are on the horizon, and we examine each.
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Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.
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Discover how the evolution of T7 polymerase is optimizing in vitro transcription for RNA therapeutics. Learn to balance performance, cost, and supply to make smart choices for your xRNA manufacturing.
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Gene delivery platforms must support a diversity of genetic engineering strategies for genomic medicine development. Learn how lipid nanoparticles can accelerate development from discovery to scale-up.
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Overcoming the challenges of manufacturing and administering a complex product to any patient is critical for delivering cell therapies. Two industry experts detail strategies to meet supply chain challenges.