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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Revolutionize advanced therapy logistics by prioritizing patient impact at every step of the supply chain to ensure life-saving treatments are delivered with integrity and precision.
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New technologies and regulatory changes are shaping safer, more efficient filling processes. Discover why innovation is key to protecting patients and advancing therapies.
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Uncover how how switching from LAL to rFC can enhance sustainability, improve testing reliability, and strengthen supply-chain resilience in endotoxin testing.
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Rapid GMP certification is possible with Annex 1-aligned aseptic workflows that reduce contamination risks. Learn how advanced automation and isolator technologies help CDMOs meet regulatory demands.
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Unclear CRO pricing leaves small biotechs vulnerable to budget swings. Transparent, itemized costs cut financial risk, sharpen planning, and build trust by setting expectations from the start.
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Bioanalysis is crucial for biopharma success. Here, Dash Bio’s Ander Tallett discusses selecting a bioanalysis CRO and collaborating effectively for assay results that accelerate drug development.
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Isolator technology enhances sterility assurance, reduces contamination risk, improves operator safety, and supports regulatory compliance, making it essential for modern aseptic fill-finish operations.