OUTSOURCING ARTICLES
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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.
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![Investment in medical and pharma business GettyImages-1299804755]( "2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture Trends")
2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture TrendsAs RNA investing matures, capital is flowing toward delivery, durability, and regulatory credibility. This column breaks down the deals, IPO signals, and venture theses shaping RNA’s 2026 winners—and why.
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![genetic research, biotechnology, molecular biology, innovation, healthcare solutions-GettyImages-2234236209]( "A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?")
A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?In 2026, advanced therapies diverge: winners pair proven biology with scalable manufacturing, delivery, and workflow fit, while others advance more slowly under operational and economic limits.
OUTSOURCING VIDEOS
Achieving cost-effective manufacturing while maintaining high quality standards today is one of the biggest challenges facing companies outsourcing mRNA/RNA development. In turn, panelists Qian Ruan, Andy Geall, and Alex Aust reflect on how and where they’ve seen the costs of mRNA-LNP manufacturing evolving/fluctuating in recent years.
A connected development pathway supports smoother scale-up and greater consistency for LNP-based therapeutics. Explore how integrated expertise across key stages helps teams accelerate progress.
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.
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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1296723604 CRO turnover training]( "How To Choose The Right CRO For Your Clinical Trial")
Selecting the right Contract Research Organization (CRO) is critical for the success of a clinical trial. This article outlines essential factors to consider during the selection process.
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![GettyImages-2196950181-factory-scientists-laboratory-tablet-training]( "Building Better CDMO Supply Chain Readiness")
As advanced therapies grow more complex, CDMOs must move beyond fragmented logistics and embrace integrated supply chain partnerships to ensure scalability, compliance, and long-term success.
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![GettyImages-1333159166-cold-chain-shipping-logistics-transportation]( "Why Shipping System Qualification Matters In Advanced Therapies")
Ensuring the integrity of advanced therapies requires documented evidence of robust shipping processes. Qualification is essential for compliance and maintaining continuity across the supply chain.
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![GettyImages-946264472-test-tube-lab]( "Improving Toxicology Testing For Inhalation Products")
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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![MRNA Technology-GettyImages-1366661187]( "Developing An mRNA-Encoded Antibody Platform To Accelerate Therapies To Clinic")
In this paper, we present the foundation of an mRNA-LNP platform for encoding and expressing therapeutic antibodies in vivo, eliminating the need for costly and time-consuming manufacturing.
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![cooperation-iStock-1226854109]( "Choosing A CDMO: 3 Considerations For New Drug Developers")
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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![Europe Globe Map Data GettyImages REV-1319209608]( "Strengthening Europe's Advanced Therapy Supply Chain")
Ensure the seamless development and commercialization of your ATMPs in Europe with integrated supply chain solutions that optimize logistics, biostorage, and regulatory compliance.
