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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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 the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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Explore aseptic filling workcells, modalities, agency approvals, and insights from six expert users that offer a peer-driven look at industry innovation and benchmarks.
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Discover how Codex® HiCap RNA Polymerase optimizes mRNA yield while reducing dsRNA byproducts for safer, more effective therapeutics.
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Strengthen your clinical development strategy by leveraging the right PCR approach and robust assay validation to deliver accurate, reliable results with confidence.
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Investing in employee training and development is not just beneficial for the employees. It also contributes significantly to the organization’s success and competitive advantage.
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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.