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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Scaling cell and gene therapy operations in EMEA demands strategic planning, regulatory alignment, and robust logistics to meet growing demand and ensure consistent delivery across diverse markets.
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Standardization and compliance in CGT supply chains are critical for minimizing risk, ensuring product integrity, and meeting regulatory demands across global manufacturing and distribution networks.
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Gene therapy immunogenicity requires platforms, judgment, and regulatory fluency beyond ADA norms. Relying on biologics criteria creates gaps; CGT expertise ensures reliable, interpretable results.
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Ensure fast, reliable, temperature-controlled logistics with a global infrastructure designed to protect critical biologic materials and keep development programs running smoothly and on schedule.
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Drug development accelerates with AI, decentralized trials, and adaptive protocols, but legacy CRO infrastructure lags. Platform-based systems enable speed, quality, automation, and continuous improvement.
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Drive the efficiency and resiliency of supply chains by integrating automation, AI, and effective communication, ensuring the successful distribution of lifesaving medicinal products.
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The success of CGTs hinges upon adherence to specific logistics protocols. Learn how the integration of AI in the pharma supply chain is poised to enhance visibility, efficiency, and compliance.