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
Together, Omega’s Jeff Atkinson & Sail Biomedicines’ Jim Nolan share their perspectives on the health of the linear mRNA and circRNA outsourcing sector.
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.
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.
While the speed of production and flexibility of mRNA are appealing, several industry challenges must still be addressed to realize the full potential and further expand its use.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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-1386852216 cell therapy]( "Accelerated Development: Gene Therapy Vs. Small Molecule")
Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.
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![GettyImages-2036497889-lab-computer-research]( "Collaboration An Untapped Fuel For Driving Biopharma R&D")
Biopharma’s future depends on collaboration. Discover how cross-industry partnerships and shared resources can accelerate innovation, overcome talent gaps, and strengthen the global R&D ecosystem.
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![Lipid Nanoparticle mRNA Vaccine GettyImages-1418152448]( "A New Centre For Continuous mRNA Manufacturing")
Explore how a partnership between academia, regulatory agencies, and manufacturing organizations has the potential to reshape the way we produce and distribute mRNA-based therapies.
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![GettyImages-1288438537 ecosystem]( "Clinical Research Is A Delicate Ecosystem")
Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors.
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![GettyImages-1421515036-genetic-DNA-helix-gene]( "Complexing RNPs: Have You Established Your Clinical Acceptance Criteria?")
When using CRISPR-Cas proteins for gene editing, it’s critical to ensure consistency and quality at each stage of the manufacturing process. The FDA recommends establishing well-defined acceptance criteria for the RNP formation step.
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![Molecule mRNA-GettyImages-1428646288]( "mRNA Therapeutic Development Through Enhanced IVT Capping Efficiency")
See how Codex HiCap RNA Polymerase supports the production of high-performance synthetic mRNA, paving the way for next-generation mRNA therapies.
