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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By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs.
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Enhance RNA manufacturing with HiCap T7 RNA Polymerase, which minimizes dsRNA, boosts expression, and reduces capping costs for superior therapeutic development.
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The greatest challenge in drug development can be finding a team capable of carrying a molecule through the complexities that lie between the research lab and the patient’s bedside. Discover three considerations that build a foundation for partnership.
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Parallel operations with a CDMO can reduce risk and accelerate timelines by enabling simultaneous process development and manufacturing. Learn how this approach supports facility design.
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Chief Commercial Officer Aruna Mor recently delivered a powerful keynote at the Advanced Therapies Congress in London, highlighting the challenges of patient access to advanced therapies.
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ISO 21973 defines global best practices for transporting cell and gene therapies, ensuring safety, quality, and consistency across complex supply chains vital to patient care.
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What are the key elements in the readiness stage of a technology transfer that are critical to your success? Explore Process Performance Qualification (PPQ) and the execution stage of PDA TR-65.