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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Cell & gene therapies are rapidly outpacing the industry's limited manufacturing capacity. Learn more about the developing network of supply chain centers built to support this growing client base.
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See why building digital, automated infrastructure is essential, and better aligns CROs with today's speed, compliance, and innovation needs.
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Pierre Catignol and Huisub Lim share their insights on current mRNA market trends, manufacturability, choosing an appropriate CDMO partner, and mRNA technology considerations.
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Late-stage therapy trials demand strict execution. Learn how local handling variations escalate into global risks and how early standardization safeguards therapeutic integrity and compliance.
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CGT's time and temperature sensitivity requires advanced consideration for storage and distribution. Monitoring the location and condition of each shipment is crucial to ensure product safety and quality.
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Ionizable lipid selection ratios shape how well lipid nanoparticles deliver nucleic acids, and empirical testing shows that similar physical properties can still produce very different performance.
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Discover how regulatory bodies are adopting a risk-based approach to address the unique challenges of genetic nanomedicines, and stakeholder engagement is essential.