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
Learn how predictive models can monitor key CQAs, such as RNA concentration and nucleoside triphosphate consumption, and explore RBP and MIT’s vision for revolutionizing biomanufacturing.
There are many different criteria for selecting a CDMO for your mRNA products. Arcturus’ Qian Ruan explains that a product’s stage of development and the specific needs inherent to that phase of development should be an important guide for companies today, especially given the expansion of the outsourcing sector and the wide range of capabilities.
In this snippet, panelist Alex Aust (with the help of several live attendee commenters) tackles a particularly tricky question: Are our outsourcing partnerships producing high quality products today, and what are the most common root causes of batch failures?
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-1465316262-computer-magnifying-glass-audit-documents]( "How Global Shifts Are Reshaping ATMP Logistics Beyond Borders")
Global economic shifts, regulatory changes, and evolving trade dynamics are transforming ATMP logistics, demanding resilient strategies to ensure uninterrupted delivery of advanced therapies worldwide.
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![Scientists Discussing GettyImages-916075464]( "Is Standardization The Key To Scalable CGT?")
Experts note CGT programs often struggle due to limited operational readiness; early standardization supports scalable, reproducible, regulatory‑ready development and helps prevent late‑stage bottlenecks.
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![GettyImages-1288118586 cell development]( "Expectations On The Pathway To GMP For Gene-Modified Cell Therapies")
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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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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![Lipid nanoparticle mRNA vaccine-GettyImages-1418152448]( "Lipids CDMO Services: Custom Excipients Tailored To Your Needs")
Advance your lipid‑based programs with a CDMO partner equipped to deliver customized excipients, proven scale‑up expertise, and reliable support from early development through commercialization.
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![GettyImages-462287059-computer-motherboard]( "Built Like A Tech Company: Why CROs Need A New Operating System")
See why building digital, automated infrastructure is essential, and better aligns CROs with today's speed, compliance, and innovation needs.
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![GettyImages-1387090964 cell and gene therapy]( "Gene And Cell Therapy: Planning For Manufacturing Success Early")
As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.
