MANUFACTURING ARTICLES
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![Financial security, wealth protection, money insurance-GettyImages-2288391875]( "Protecting The Platform: Trade Secret Protection For RNA Biotech Companies")
Protecting The Platform: Trade Secret Protection For RNA Biotech CompaniesAs RNA therapeutics grow more complex and collaborative, trade secrets are becoming an increasingly important part of protecting valuable platform innovation.
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![creativity, innovation-GettyImages-2209122228]( "Engineering RNA Agonists For Systemic Immunity Without Systemic Toxicity")
Engineering RNA Agonists For Systemic Immunity Without Systemic ToxicityKrieg 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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![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.”
MANUFACTURING VIDEOS
As a field, we’ve been aligned around CQAs for our mRNA drug substances. However, differences in translation between highly similar mRNAs (i.e., (same sequence, same design, different manufacturers) raises the question of whether we’re missing any QAs/CQAs. Here, Advancing RNA Live panelists Elaine Peters and Ilya Shestolapov share their take.
Is enzymatic ligation merely a "volume play"? In this segment, Advancing RNA Live speakers Claire McCleod and Jill Caswell challenge this belief, explaining the extent at which this paradigm shift also unlocks higher siRNA purity.
Learn about a small oligonucleotide synthesizer with big impact that features a user-friendly interface, compact footprint, and more. This small scale system is user friendly and supports scale up.
In this Advancing RNA Live clip, panelists Venkat Krishnamurthy and April Sena home in on the economic, molecular, and biological challenges complicating the transition to enzymatic ligation today.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Feature Image 1]( "mRNA Product Purification Process Strategies")
Impurities from IVT can induce undesired immune responses and negatively impact translation efficiency. Explore the pros and cons of each option for mRNA purification.
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![GettyImages-1310024666-genetic-digital-dna]( "How Nanoparticle Platforms Are Unlocking Genetic Medicine's Potential")
Explore how the HIT SCAN platform accelerates gene therapy delivery by screening polymeric nanoparticles, enhancing precision and regulatory pathways for next-generation genetic medicines.
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![iStock-1295693740-covid-coronavirus-vaccine-mrna]( "Developing A Scalable RNA-LNP Drug Product For Clinical Translation")
Accelerate essential process development activities with instrumentation solution allowing for highly reproducible and scalable production of RNA-LNPs.
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![GettyImages-155373764-cryopreservation-cold-chain]( "Expanding Supply Chain Solutions With Vein-To-Vein Offerings")
Leveraging a partner experienced in controlled temperature GMP-compliant storage, secondary packaging/labeling, and kit production is critical to advance your CGT project to market.
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![GettyImages-523752319 research, lab, sample]( "Size Matters: Mastering Size Exclusion For Oligos")
Learn how to separate molecules strictly by size, effectively remove salts, and select the correct pore specifications for a gentle, non-destructive purification workflow.
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![Gene therapy data GettyImages-1054555460]( "Let The Future Start Today: Development Of Better LNP-Based Genetic Medicines")
Discover how you can accelerate the time to patients for new vaccines and therapies with innovative, streamlined technology that is quicker and more intuitive.
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![injecting vaccine vaccination-GettyImages-665515600]( "21st Century Manufacturing Of Injectable Pharmaceuticals")
Discover how rising competition, niche patient populations, and evolving therapies are reshaping sterile injectable drug development with cutting-edge technologies.
