OUTSOURCING ARTICLES
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![Global health safety regulation-GettyImages-2245658628]( "How Informal FDA Feedback Is Quietly Driving RNA Capital Allocation")
How Informal FDA Feedback Is Quietly Driving RNA Capital AllocationSubtle FDA signals — especially in pre-IND talks — are quietly shaping RNA investment. Early regulatory feedback on CMC and comparability now drives how investors assess risk and allocate capital.
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![Investment in medical and pharma business GettyImages-1299804755]( "2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture Trends")
2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture TrendsAs RNA investing matures, capital is flowing toward delivery, durability, and regulatory credibility. This column breaks down the deals, IPO signals, and venture theses shaping RNA’s 2026 winners—and why.
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![genetic research, biotechnology, molecular biology, innovation, healthcare solutions-GettyImages-2234236209]( "A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?")
A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?In 2026, advanced therapies diverge: winners pair proven biology with scalable manufacturing, delivery, and workflow fit, while others advance more slowly under operational and economic limits.
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![Potter at work-GettyImages-1142834523]( "Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026")
Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026Here, in part two of this multi-part series, we hear from Melissa Bonner, CSO of nChroma Bio and Andy Geall, CDO of Replicate Biosciences, who call attention to several developments of the past year they’ve been watching and how they see these developments informing our conversations about and work with mRNA in 2026 and beyond.
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![GettyImages-1128195910-vial-white-powder-lyophilization]( "Four Reasons You Should Choose Lyophilization for Your Next Project")
Four Reasons You Should Choose Lyophilization for Your Next ProjectLyophilization ensures product stability, extends shelf life, supports sensitive formulations, and simplifies storage and transport, making it a critical choice for modern drug development projects.
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![path of exponential growth-GettyImages-2229192052]( "Trends In Oligo Scale-Up & Delivery & How They're Impacting Manufacturing")
Trends In Oligo Scale-Up & Delivery & How They're Impacting ManufacturingHere, a panel of experts at the RNA Leaders Conference gives a fantastic overview of where we are today and why, as one expert so nicely put it, “This is one of the most fun times to be an oligo scientist or chemist.”
OUTSOURCING VIDEOS
Reliable sterile manufacturing requires tailored support and consistent execution. Collaboration and strong quality systems help teams advance complex injectable products with confidence.
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.
In part two of this webinar series, presenters focus on avoiding potential risks, such as unexpected budget changes and unplanned change orders, that could jeopardize the success of a clinical trial.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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![nanoparticles-drug molecule-GettyImages-1428647836]( "Accelerate LNP Manufacturing With Automated Process Development")
Manual LNP formulation introduces process variability that threatens particle quality and yield. As programs scale toward clinical production, maintaining strict control over CQAs becomes essential.
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![GettyImages-1370115311 outsourcing]( "Contract Design And Development Vs. In-House: Finding The Best Fit")
Outsourcing medical device R&D to Contract Development Organizations (CDOs) aids innovation, scales resources, and overcomes constraints. Strategic evaluation ensures successful partnerships.
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![Decision Timeline: Considerations In Selecting An Outsourced Solution]( "Is Not Using A CDMO Slowing Down Your Process Development?")
Consider what process development capabilities you have versus what you could possibly gain from working with a CDMO to not only be successful but also improve your chances of getting to market sooner.
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![GettyImages-1324966781-mrna-vaccine-covid-coronavirus]( "Addressing And Adapting To Evolving mRNA Market Trends")
Pierre Catignol and Huisub Lim share their insights on current mRNA market trends, manufacturability, choosing an appropriate CDMO partner, and mRNA technology considerations.
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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-2183428964 lab]( "Analytical Method Release And Stability Platform For RNA Drug Substance")
We offer comprehensive analytical support across the R&D space, including method development, validation, process characterization, in-process testing, process validation, and GMP release testing.
