OUTSOURCING 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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Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)
European RNA biotech leaders can accelerate U.S. success by aligning fundraising, partnerships, manufacturing, hiring, and regulatory strategy from day one.
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The Delivery Challenge For In Vivo Cell Engineering
As RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.
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Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The Check
A practical framework for evaluating whether an RNA company has the science, strategy, scalability, and discipline to become a lasting platform.
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Bridging The Atlantic: A European Executive's Guide To Entering The U.S. RNA Market (Pt. 1)
A practical roadmap for European biotech leaders navigating FDA expectations, market entry, and the strategic decisions that shape U.S. expansion.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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What sustainable manufacturing processes best address Oligonucleotide environmental impact while maintaining scalability?
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Ensure the seamless development and commercialization of your ATMPs in Europe with integrated supply chain solutions that optimize logistics, biostorage, and regulatory compliance.
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Operational consistency across global facilities protects product integrity and supports growth. Standardized processes reduce risk, minimize variability, and strengthen quality across markets.
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See how Codex HiCap RNA Polymerase supports the production of high-performance synthetic mRNA, paving the way for next-generation mRNA therapies.
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Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.
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Early integration of standardized, GMP-aligned cryopreservation improves consistency, documentation, and scalability in advanced therapy programs as they progress toward regulatory submissions.
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Discover how Codex® HiCap RNA Polymerase optimizes mRNA yield while reducing dsRNA byproducts for safer, more effective therapeutics.