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
Explore how optimized analytical testing, reduced material wastage, and advanced sterile fill-finish technologies can work together to preserve valuable GMP material without compromising quality.
Discover how advanced mRNA manufacturing innovations, including optimized RNA synthesis and scalable LNP encapsulation, are accelerating therapeutic development.
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 the insight and strategic flexibility needed to confidently navigate the unique scientific, regulatory, and documentation challenges of gene therapy development.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1869998960 patient, doctor, clincial trial]( "Phase IIb Trial: Evaluating A Novel Treatment For Locally Advanced Or Metastatic Breast Cancer")
This case study highlights a successful Phase IIb clinical trial conducted by an Indian biotech company evaluating a novel treatment for Locally Advanced or Metastatic Breast Cancer.
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![cell-gene-therapy-GettyImages-1407359737]( "Unmatched Beginnings For Late-Phase Success")
Early research choices shape outcomes. Focusing on reproducibility, scalability, regulatory fit, and supply stability early cuts risk, prevents delays, and supports smoother development progress.
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![Europe Globe Map Data GettyImages REV-1319209608]( "Strengthening Europe's Advanced Therapy Supply Chain")
Ensure the seamless development and commercialization of your ATMPs in Europe with integrated supply chain solutions that optimize logistics, biostorage, and regulatory compliance.
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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-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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![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.
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![jhs_encourages_current_and_potential_customers_to_visit_our_facilities]( "Step-By-Step Guide To Tech Transfer Preparation And Execution")
How does a sponsor accurately transfer detailed knowledge about its product composition, development, and current manufacturing processes to its CDMO?
