OUTSOURCING ARTICLES
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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.
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![Scattered thoughts-GettyImages-2178092695]( "The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational Friction")
The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational FrictionScientific breakthroughs may spark innovation, but operational excellence ultimately determines which advanced therapies reach patients.
OUTSOURCING VIDEOS
The right bioanalysis CRO accelerates progress, while the wrong one can derail outcomes. When every provider claims speed and credibility, how do you confidently choose the right partner?
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.
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.
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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Lipid nanoparticle mRNA vaccine-GettyImages-1418152448]( "Lipids CDMO Services: Custom Excipients Tailored To Your Needs")
Advance your lipid‑based programs with a CDMO partner equipped to deliver customized excipients, proven scale‑up expertise, and reliable support from early development through commercialization.
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![GettyImages-1327977866-cell-culture-sample-laboratory]( "Choosing The Best mRNA Manufacturing Strategy")
Choosing the right mRNA manufacturing model can define your success. Learn how to weigh control, cost, and flexibility to build a strategy that supports innovation and long-term growth.
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![GettyImages-1284529278-syringe-pre-filled-PFS]( "New Perspectives On Accelerating Genetic Nanomedicines Through The Regulatory Pathway")
Discover how regulatory bodies are adopting a risk-based approach to address the unique challenges of genetic nanomedicines, and stakeholder engagement is essential.
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![GettyImages-507526558-petri-dish-microbiology]( "Partnering For Success: Microbiological Testing In Contract Laboratories")
Outsourcing microbiological testing goes beyond method selection. Learn how early lab engagement, redundancy planning, and regulatory alignment protect your release timelines and compliance.
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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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![Developing mRNA Vaccines GettyImages-1307593959]( "Improving Pre-Clinical Study Efficiency With mRNA-LNP Technology")
Uncover how Repair Biotechnologies, in collaboration with Vernal Biosciences, helped to pave the way for the next generation of breakthrough treatments for cholesterol and aging-related diseases.
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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.
