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
Gain valuable insights into the role of sponsor-side Clinical Operations leadership, the risks of over-relying on CROs, and key strategies for fostering collaboration between sponsors and partners.
Tighter production schedules leave little room for equipment disruption. Get support that can strengthen maintenance strategies, reduce operational risk, and help internal teams sustain performance.
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.
Advancing RNA panelists Alex Aust, Qian Ruan, and Andy Geal share their thoughts on the ways in which outsourcing firms are approaching mRNA development today, as well as why outsourcing — as opposed to building a GMP facility — remains critical for (x)RNA biotechs today.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Cleanroom Scientists Using Tablet GettyImages-1341292153]( "High-Throughput Platform Propels Gene Editing Therapy Research")
Explore the potential of polymeric nanoparticles (PNPs) as an alternative to viral vectors. PNPs offer design flexibility, enabling larger payloads, targeted release, and minimized side effects.
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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?
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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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![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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![GettyImages-1421515036-genetic-DNA-helix-gene]( "Complexing RNPs: Have You Established Your Clinical Acceptance Criteria?")
Ensuring consistency and quality at every manufacturing stage is critical for CRISPR-Cas gene editing. To achieve this, the FDA recommends establishing well-defined acceptance criteria for RNP formation.
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![CGT-cro-GettyImages-2256752073]( "What Sponsors Get Wrong When Selecting A CRO")
Gene therapy immunogenicity requires platforms, judgment, and regulatory fluency beyond ADA norms. Relying on biologics criteria creates gaps; CGT expertise ensures reliable, interpretable results.
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![6 trends in biologics Blog Cover]( "6 Trends Redefining Biologics Manufacturing In 2026")
Biologics manufacturing is evolving through smarter fill technologies, onshoring, advanced automation, and data driven processes that improve efficiency, reduce risk, and protect product value.
