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
TFF Pharmaceuticals’ Kayla Hannon and University of Sheffield’s Dr. Zoltán Kis discuss the cost and capacity implications of therapeutic demand surges in this Surge Manufacturing for Biopharma Resilience segment.
Gain insights into overcoming the challenges in lipid nanoparticle (LNP) formulation, explore critical aspects of the process and analytical development of LNPs, and much more.
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.
Here, we walk you through our groundbreaking, enzymatic DNA manufacturing process that enables the production of linear DNA templates for IVT mRNA synthesis — without the use of cells.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![cell-gene-therapy-GettyImages-2157300524]( "Safe, Scalable And GMP-Ready DNA")
Cell‑free synthetic DNA provides a scalable, safer alternative to plasmids by eliminating bacterial risks, simplifying quality control, and enabling complex sequences under GMP‑aligned conditions.
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![GettyImages-1409734937-3d-rendering-rna-dna]( "Current Challenges In The Plasmid DNA Manufacturing Process")
PolyA tail stability shapes mRNA potency, consistency, and manufacturability. Addressing integrity early reduces variability, simplifies workflows, and supports reliable clinical scale‑out.
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![mRNA-analysis-blue]( "Exploring The Spatial Distribution Of mRNA-Lipid Nanoparticles Using MALDI MSI")
Learn how leveraging high-resolution MALDI-MSI can advance the development of lipid nanoparticle-based therapies, uncovering spatial biodistribution, pharmacokinetics, and organ-specific variability.
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![Warehouse management innovative software GettyImages-1355815870]( "Reducing Lead Time, Delivering >99.5% OTIF")
Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.
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![iStock-528606286-handshake-partnership-partner-agreement]( "Is Your Biologics CDMO Transparent?")
Transparency and collaboration with a CDMO are vital for reducing risk and protecting IP. Discover four essential practices, from clear communication to IP safeguards, that help build trust.
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![GettyImages-547131922 research, regulatory, lab]( "What's Next For ATMP Regulation In EMEA")
Fragmented national regulations for pricing, customs, and reimbursement demand tailored supply chain strategies. Adapting to country-specific hurdles is essential for product integrity and patient access.
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![GettyImages-1152347341 RNA success]( "Expertise In RNA Therapies: Client Success Stories")
Learn how to navigate the complex challenges of accelerating therapies through clinical development to regulatory approval and commercialization.
