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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Effectively applying compendial testing to cell and gene therapy products requires strategic test ordering and specialized micro-equipment to manage limited volume and accelerate turnaround time.
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Redundant requalification tasks can delay late-stage clinical expansion. Standardized protocols reduce repeat validation, lower costs, maintain quality, and support commercialization.
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Personalized cancer vaccines face a DNA production bottleneck. Synthetic approaches speed timelines, boost consistency, and simplify workflows to deliver individualized therapies faster.
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Cell‑free synthetic DNA provides a scalable, safer alternative to plasmids by eliminating bacterial risks, simplifying quality control, and enabling complex sequences under GMP‑aligned conditions.
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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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Review a breakdown of how to requalify every shipper for its impending transit and ensure your therapy material maintains integrity and safety during transportation.
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Drive the next wave of cell and gene therapy innovation by overcoming operational, funding, and regulatory challenges to deliver life-changing treatments to patients faster.