OUTSOURCING ARTICLES
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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.
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The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational Friction
Scientific breakthroughs may spark innovation, but operational excellence ultimately determines which advanced therapies reach patients.
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RNA Therapeutics: Why CMC Strategy Will Define The Next Decade
As RNA matures into an industrial platform, long-term success will depend less on discovery and more on scalable CMC systems, integration, and execution.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Fragmented pre‑clinical supply chains create avoidable delays and risks; unifying cryopreservation, logistics, and storage early improves consistency, reduces operational gaps, and supports smoother progression into clinical phases.
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Delve into the exciting potential of OVs, including the critical role of cell and virus seed banks, and discover key considerations for establishing cell and virus banks for OV production.
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Fragmented supply chains increase risk and delay execution. Integration is key to establish a unified framework that enhances control, reduces administrative burden, and ensures program predictability.
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Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.
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To overcome challenges in oligonucleotide LC/MS bioanalysis, consider optimizing probe design by evaluating alternative chemistries like PNA for improved recovery and chromatographic performance.
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In addition to codifying some best practices, R3 recommends that sponsors adopt an approach to identifying and managing areas of risk to mitigate potential issues and enhance overall success.
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Explore how a partnership between academia, regulatory agencies, and manufacturing organizations has the potential to reshape the way we produce and distribute mRNA-based therapies.