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
Hear from inSeption Group clients as they share their experiences, recount their journeys and highlight the exceptional service and support they received.
Speaking of outsourcing, Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus share what they’re manufacturing in house, what they’re outsourcing, and why in this segment from our recent CMC, Scale Up, & The Road To mRNA Regulatory Approval event.
Custom lipid programs depend on how process development and manufacturing teams collaborate, from first design through scale-up to GMP production for LNP-based therapies.
RNA therapeutics are reshaping disease treatment, but success requires coordinated expertise in plasmid production, RNA synthesis, formulation, analytics, and manufacturing.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-522871505-aseptic-filling-sterile-cleanroom]( "Sterile Injectables: Why Innovation Matters More Than Ever")
New technologies and regulatory changes are shaping safer, more efficient filling processes. Discover why innovation is key to protecting patients and advancing therapies.
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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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![GettyImages-2196950181-factory-scientists-laboratory-tablet-training]( "Building Better CDMO Supply Chain Readiness")
As advanced therapies grow more complex, CDMOs must move beyond fragmented logistics and embrace integrated supply chain partnerships to ensure scalability, compliance, and long-term success.
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![Documentation Traps]( "Shifting The Approach: 4 Tactics For ICH E6(R3) Implementation")
In addition to codifying some best practices, R3 recommends that sponsors adopt an approach to identifying and managing areas of risk to mitigate potential issues and enhance overall success.
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![GettyImages-1346675635-laboratory-analysis-research-microscope]( "Minimizing Volume Requirements, Turnaround Time For Compendial Testing")
Effectively applying compendial testing to cell and gene therapy products requires strategic test ordering and specialized micro-equipment to manage limited volume and accelerate turnaround time.
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![GettyImages-1331571740-supply-chain-sourcing-logistics-tracking]( "Built Or Bought? Why Biotechs Are Outsourcing Supply Chain Infrastructure")
Scaling advanced therapies requires navigating extreme logistics and regulatory hurdles. Learn why moving to a flexible, outsourced model is essential for freeing capital and mitigating global risk.
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![Outsourcing Business Human Resources--GettyImages-1305829382]( "Enabling CDMOs To Focus On Core Priorities")
Explore innovative solutions for CDMO's striving to remain competitive as the biopharmaceutical market grows and evolves.
