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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Automated, closed cryo‑processing of leukapheresis preserves cell quality and functionality, enabling flexible, reproducible starting material for both autologous and allogeneic CAR‑T manufacturing.
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Small, early operational decisions accumulate over time, creating hidden variability that emerges at scale, making standardization essential for stability, reproducibility, and regulatory confidence.
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Fresh starting materials add variability and fragility, while frozen inputs create predictable, scalable workflows that improve consistency, lower risk, and support smoother early‑phase development.
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In this paper, we present the foundation of an mRNA-LNP platform for encoding and expressing therapeutic antibodies in vivo, eliminating the need for costly and time-consuming manufacturing.
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Early research choices shape outcomes. Focusing on reproducibility, scalability, regulatory fit, and supply stability early cuts risk, prevents delays, and supports smoother development progress.
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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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Choosing the right mRNA manufacturing model can define your success. Learn how to weigh control, cost, and flexibility to build a strategy that supports innovation and long-term growth.