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.
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.
Discover how our advanced capabilities in Hopkinton, MA, are overcoming the challenges of large-scale RNA therapeutic manufacturing, enabling the efficient production of complex srRNA and mRNA therapies.
In this Advancing RNA Live clip, CMC Consultant Sujit Jain explains the numerous ways that adding targeting ligands “stress tests” the standard LNP manufacturing platform, as well as outlines which capabilities are most important for companies to consider when selecting an outsourcing partner for their active delivery strategies.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-1051617224-automation]( "Accelerate GMP Certification With Annex 1-Compliant Aseptic Automation")
Rapid GMP certification is possible with Annex 1-aligned aseptic workflows that reduce contamination risks. Learn how advanced automation and isolator technologies help CDMOs meet regulatory demands.
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![GettyImages-1371707479-lab-mask-team-partnership]( "The Future Of CGT: Phase-Appropriate Plasmid DNA Manufacturing")
Effective CGT development hinges on phase-appropriate manufacturing. Matching manufacturing rigor to the clinical phase ensures the right quality at the right time while reducing costs and accelerating timelines.
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![viral clearance services]( "Choosing A CDMO That Can Grow With A Viral Program")
Viral modalities demand more from CDMO selection: relevant experience, rigorous tech transfer, analytical readiness, and a clear path to scale matter more than equipment alone.
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![GettyImages-1622519985 cryopreservation, cold chain]( "Standardization Where It Matters Most")
Freezing doesn’t ensure consistency. Standardized cryopreservation removes site‑to‑site variability, providing predictable starting materials and lowering scientific and operational risk.
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![Lyo Oncology Scale Up Landing Page Photo]( "LYO Cycle Development Ensures Success For Oncology Drug Scale-Up")
An optimized lyophilization cycle removes excess moisture during scale‑up by adjusting drying for larger equipment, improving stability, maintaining efficiency, and supporting clinical validation.
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![GettyImages-1185624320-scientist-lab-smiling]( "Biologics CDMO: 3 Qualities Often Overlooked")
A partnership can deliver more than process support. Transparency, regulatory expertise, and IP protection are critical benefits that safeguard your autonomy and innovation while enabling global success.
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![GettyImages-1465316262-computer-magnifying-glass-audit-documents]( "How Global Shifts Are Reshaping ATMP Logistics Beyond Borders")
Global economic shifts, regulatory changes, and evolving trade dynamics are transforming ATMP logistics, demanding resilient strategies to ensure uninterrupted delivery of advanced therapies worldwide.
