OUTSOURCING ARTICLES
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![economy law of supply and demand-GettyImages-1263079550]( "Is mRNA Manufacturing Overbuilt?")
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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![Justified Risk-GettyImages-2232143649]( "What Oligo Manufacturing Risks Are We Underestimating?")
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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![MacKay suspension bridge-GettyImages-2281791194]( "Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)")
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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![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.
OUTSOURCING VIDEOS
Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.
Reliable sterile manufacturing requires tailored support and consistent execution. Collaboration and strong quality systems help teams advance complex injectable products with confidence.
Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.
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-1443973272 research]( "Going Global: How Working With A CRO Can Benefit Clinical Trials")
Contract research organizations can be invaluable partners in clinical trials. Dive into the full spectrum of benefits you'll experience by partnering with a globally established and well-resourced CRO.
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![GettyImages-2167387195-computer-graphs-hand-team-digital]( "Resilience By Design: Lessons From Real-World Disruption")
Resilience is the bridge to patient access. Discover how to design your logistics with intentional flexibility to withstand real-world disruptions and protect product integrity under pressure.
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![GettyImages-1622519985 cryopreservation, cold chain]( "Standardization Where It Matters Most")
Freezing doesn’t ensure consistency. Standardized cryopreservation removes site‑to‑site variability, providing predictable starting materials and lowering scientific and operational risk.
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![iStock-1137893250-shipping-logistics]( "The Future Of Gene Therapy Logistics – A Pivotal Moment")
Ensure the safe, reliable, and future-ready delivery of gene therapies with cutting-edge temperature-controlled logistics solutions.
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![GettyImages-522871505-aseptic-filling-sterile-cleanroom]( "Sterile Injectables: Why Innovation Matters More Than Ever")
New technologies and regulatory changes are shaping safer, more efficient filling processes. Discover why innovation is key to protecting patients and advancing therapies.
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![Documentation Traps]( "Shifting The Approach: 4 Tactics For ICH E6(R3) Implementation")
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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![Lyo Oncology Scale Up Landing Page Photo]( "LYO Cycle Development Ensures Success For Oncology Drug Scale-Up")
An optimized lyophilization cycle removes excess moisture during scale‑up by adjusting drying for larger equipment, improving stability, maintaining efficiency, and supporting clinical validation.
