OUTSOURCING ARTICLES
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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.
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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.
OUTSOURCING VIDEOS
Stay ahead in mRNA therapeutic development by mastering the essential quality systems, process controls, and analytical methods required for robust GMP production and efficient manufacturing.
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.
In this segment, Replicate Biosciences’ Andy Geall, Qian Ruan, & Alex Aust identify the most promising technological and raw material innovations that are influencing the drug substance and drug product production processes at CDMOs.
In part two of this webinar series, presenters focus on avoiding potential risks, such as unexpected budget changes and unplanned change orders, that could jeopardize the success of a clinical trial.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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![Cryoport Elite]( "Meeting The Challenges Of Gene Therapy Logistics With The Cryoport Elite Ultra Cold")
Explore how innovative logistics solutions are addressing the critical challenges of gene therapy transportation to ensure safe, reliable delivery of these life-changing treatments.
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![BioSpring Waters Inc]( "Learn How Compliance-Ready LC-MS Workflows for Oligonucleotides Can Expand your Analytical Services Portfolio")
CMO invests in solution to ensure data integrity and meet regulatory requirements as they expand their oligonucleotide manufacturing and analysis services.
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![Developing mRNA Vaccines GettyImages-1307593959]( "Improving Pre-Clinical Study Efficiency With mRNA-LNP Technology")
Uncover how Repair Biotechnologies, in collaboration with Vernal Biosciences, helped to pave the way for the next generation of breakthrough treatments for cholesterol and aging-related diseases.
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![GettyImages-1370115311 outsourcing]( "Contract Design And Development Vs. In-House: Finding The Best Fit")
Outsourcing medical device R&D to Contract Development Organizations (CDOs) aids innovation, scales resources, and overcomes constraints. Strategic evaluation ensures successful partnerships.
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![GettyImages-506999858-scientists-cell-culture-lab-development]( "Building Bioanalysis Infrastructure For Modern Drug Development")
Drug development accelerates with AI, decentralized trials, and adaptive protocols, but legacy CRO infrastructure lags. Platform-based systems enable speed, quality, automation, and continuous improvement.
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![Car-T cell attacking cancer cell-GettyImages-2252478724]( "Automated Cryo‑Processed Leukapheresis For CAR‑T Manufacturing")
Automated, closed cryo‑processing of leukapheresis preserves cell quality and functionality, enabling flexible, reproducible starting material for both autologous and allogeneic CAR‑T manufacturing.
