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
Developing a client-sponsored Target Product Profile (TPP) and Analytical Target Profile (ATP) is critical to move your drug product to clinic efficiently and meet acceptance criteria.
In this clip, Advancing RNA Live panelist Venkat Krishnamurthy unpacks how solid-phase synthesis has been improving to overcome current challenges with gRNA production, while Max De Long and April Sena share their perspectives on the maturity of current CDMO platforms for enzymatic ligation of gRNA.
Join us in this video as we delve into invaluable tips, cutting-edge tools, and unwavering support that Cytiva offers to facilitate your documentation progress.
Max De Long, April Sena, and Venkat Krishnamurthy share their perspectives on the current “health” of CDMO SPOS and enzymatic ligation platforms, while also highlighting the “red flags” to look out for when taking stock of a CDMOs capabilities.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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![cro-vendor-selection-GettyImages-1220794892]( "How Smaller Biotechs Are Rethinking CRO Relationships Post-Pandemic")
Smaller biotechs are rethinking CRO partnerships, valuing speed, scientific access, flexibility, and transparent pricing over scale — driven by pandemic lessons and a sharper focus on operational fit.
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![GettyImages-1327112218 Scientist using a laptop in a laboratory]( "Tackling Antimicrobial Resistance")
Learn how three companies collaborated to develop a new antibiotic to address the increasing development of antimicrobial resistance (AMR) that threatens the global health landscape.
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![Regulatory network digital EHR EMR patient data GettyImages-1298626492]( "Getting CMC Right For Emerging Technologies")
Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.
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![GettyImages-2183428964 lab]( "Analytical Method Release And Stability Platform For RNA Drug Substance")
We offer comprehensive analytical support across the R&D space, including method development, validation, process characterization, in-process testing, process validation, and GMP release testing.
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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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![iStock-528606286-handshake-partnership-partner-agreement]( "Transitioning From Using RUO To cGMP Chemicals For Clinical Trials")
Learn about the common challenges and risks associated with accelerating your molecule's timeline from lab to clinic, along with important supply chain considerations for emerging biopharma companies.
