OUTSOURCING ARTICLES
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![GettyImages-1494348289_lab microscope]( "The Delivery Challenge For In Vivo Cell Engineering")
The Delivery Challenge For In Vivo Cell EngineeringAs 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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![Pen being used to write a check-GettyImages-173602091]( "Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The Check")
Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The CheckA practical framework for evaluating whether an RNA company has the science, strategy, scalability, and discipline to become a lasting platform.
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![AI, artificial intelligence, dna research-GettyImages-2192601384]( "Bridging The Atlantic: A European Executive's Guide To Entering The U.S. RNA Market (Pt. 1)")
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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![Scattered thoughts-GettyImages-2178092695]( "The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational Friction")
The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational FrictionScientific breakthroughs may spark innovation, but operational excellence ultimately determines which advanced therapies reach patients.
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![DNA target nanodrugs-GettyImages-1405926704]( "RNA Therapeutics: Why CMC Strategy Will Define The Next Decade")
RNA Therapeutics: Why CMC Strategy Will Define The Next DecadeAs RNA matures into an industrial platform, long-term success will depend less on discovery and more on scalable CMC systems, integration, and execution.
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![Global health safety regulation-GettyImages-2245658628]( "How Informal FDA Feedback Is Quietly Driving RNA Capital Allocation")
How Informal FDA Feedback Is Quietly Driving RNA Capital AllocationSubtle FDA signals — especially in pre-IND talks — are quietly shaping RNA investment. Early regulatory feedback on CMC and comparability now drives how investors assess risk and allocate capital.
OUTSOURCING VIDEOS
Gain valuable insights into key considerations when selecting lipid excipients for LNP formulations and the process development steps necessary to advance them to GMP manufacturing and clinical trials.
In this Advancing RNA Live clip, CMC Consultant Sujit Jain explains the numerous ways that adding targeting ligands “stress tests” the standard LNP manufacturing platform, as well as outlines which capabilities are most important for companies to consider when selecting an outsourcing partner for their active delivery strategies.
Three Advancing RNA Live panelists share their greatest needs in outsourcing partnerships for mRNA/RNA-LNP products and where sponsors should be the most prescriptive when drafting an MSA with an outsourcing partner.
While the speed of production and flexibility of mRNA are appealing, several industry challenges must still be addressed to realize the full potential and further expand its use.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1622519985 cryopreservation, cold chain]( "Regulatory Readiness Is Built Early")
Building regulatory readiness early in cell and gene therapy development protects product integrity, prevents costly delays, and secures long-term program viability.
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![GettyImages-515631085-cryopreservation-cryo-cold]( "Expand Trial Footprints Without Expanding Cryopreservation Risk")
Transitioning from fresh to frozen starting material stabilizes cell therapy inputs, but isolated workflows introduce risk. Integrated logistics safeguard quality as trial footprints expand.
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![Modern Medical Laboratory, biotechnology research-GettyImages-2266784532]( "When Local Variation Becomes Global Risk In Phase III")
Late-stage therapy trials demand strict execution. Learn how local handling variations escalate into global risks and how early standardization safeguards therapeutic integrity and compliance.
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![GettyImages-1295693748-mRNA]( "Addressing Challenges In mRNA Drug Development And Manufacturing")
mRNA-based drug products serve as an ideal platform for use in infectious disease, protein replacement, and immuno-oncology applications due to the simplicity of manufacturing and robust immune response.
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![GettyImages-1333406903-liquid-nitrogen-cryopreservation-cold-chain]( "Accelerate Efficiency By Decoupling Collection From Manufacturing")
Cryopreservation eliminates rigid timelines by decoupling collection from production, providing the flexibility needed to optimize facility use and stabilize advanced therapy supply chains.
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![GettyImages-1783586499 regulatory compliance]( "Supporting Compliance And Reducing Risk In Gene Therapy Logistics")
Ensure the safe, compliant, and seamless delivery of gene therapies by leveraging advanced logistics solutions designed to meet stringent regulatory standards and mitigate risk at every stage.
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![GettyImages-1437855768-lipid-nanoparticle-lnp-mrna vaccine]( "The Current And Future Value Of mRNA Vaccines And Therapeutics")
Discover how decades of research have propelled mRNA technology to the forefront of therapeutic development and learn how our expertise is advancing mRNA drug development.
