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
While the speed of production and flexibility of mRNA are appealing, several industry challenges must still be addressed to realize the full potential and further expand its use.
Partner with a proven team to streamline your facility validation and environmental monitoring programs with flexible, cGMP-compliant services and reliable on-site collection.
Gain the insight and strategic flexibility needed to confidently navigate the unique scientific, regulatory, and documentation challenges of gene therapy development.
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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1054148730-clinical-outsourcing-partner-FSP]( "The Shift Toward Flexible FSP Models")
Flexible FSP models are reshaping clinical outsourcing by offering sponsors scalable, cost-predictable partnerships that preserve control, enhance quality, and support long-term strategic goals.
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![supply chain checklist pharmaceuticals-GettyImages-1616023386]( "Why Supply Chain Integration Matters In Advanced Therapy Manufacturing")
Fragmented supply chains increase risk and delay execution. Integration is key to establish a unified framework that enhances control, reduces administrative burden, and ensures program predictability.
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![Molecular biology, mRNA strands, genetics-GettyImages-2198118160]( "Transitioning mRNA Production To cGMP Requires Early Process Engagement")
Early choices in capping strategy, IVT conditions, raw materials, and downstream design shape yield, cost, and quality in mRNA manufacturing, and can determine whether a cGMP campaign succeeds.
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![GettyImages-1355122387 RNA]( "Transcribing RNA With Higher Purity, Activity While Using Less Cap Analog")
Enhance RNA manufacturing with HiCap T7 RNA Polymerase, which minimizes dsRNA, boosts expression, and reduces capping costs for superior therapeutic development.
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![deep freezing cryopreservation GettyImages-952307842]( "Pioneering The Future Of Pharmaceutical Supply Chains")
Drive the efficiency and resiliency of supply chains by integrating automation, AI, and effective communication, ensuring the successful distribution of lifesaving medicinal products.
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![GettyImages-1296723604 CRO turnover training]( "How To Choose The Right CRO For Your Clinical Trial")
Selecting the right Contract Research Organization (CRO) is critical for the success of a clinical trial. This article outlines essential factors to consider during the selection process.
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![GettyImages-163113211-south-africa-globe]( "Building Local Biomanufacturing Capacity In South Africa")
Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.
