OUTSOURCING ARTICLES
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![DNA target nanodrugs-GettyImages-1405926704]( "RNA Therapeutics: Why CMC Strategy Will Define The Next Decade")
RNA Therapeutics: Why CMC Strategy Will Define The Next DecadeAs RNA matures into an industrial platform, long-term success will depend less on discovery and more on scalable CMC systems, integration, and execution.
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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.
OUTSOURCING VIDEOS
With decades of experience, we offer a flexible and collaborative partnership model for manufacturing excellence that enables our clients to increase speed to market with full regulatory confidence.
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.
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.
Developing a client-sponsored Target Product Profile (TPP) and Analytical Target Profile (ATP) is critical to move your drug product to clinic efficiently and meet acceptance criteria.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![cell-gene-therapy-GettyImages-1407359737]( "Unmatched Beginnings For Late-Phase Success")
Early research choices shape outcomes. Focusing on reproducibility, scalability, regulatory fit, and supply stability early cuts risk, prevents delays, and supports smoother development progress.
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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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![Manufacturing]( "Bridging The Skills Gap In Biopharma")
Employees must have the skills to effectively execute on process development and manufacturing operations. How do you ensure they are updated on complex bioprocessing techniques and technologies?
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![mRNA GettyImages-1428646288]( "Advanced Therapies Going Mainstream: Are We There Yet?")
Advanced therapies are nearing mainstream adoption, with cell, mRNA, and oligonucleotide treatments expanding into broader indications. Learn what’s driving this shift and what manufacturers must do.
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![Outsourcing Business Human Resources--GettyImages-1305829382]( "Strategies For A More Secure Outsourcing Bottom Line")
A panel of experts from across the pharmaceutical/biopharmaceutical industry recently shared their experiences in mitigating financial risk before partnering with a contract research organization (CRO).
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![GettyImages-1027137582-lab-scientist-research]( "An In-Depth Analysis Of CRO Operations And Impact On Drug Development")
Get a full overview of the role CROs play in clinical trials and their impact on site selection, site monitoring, patient recruitment, managing data, and more.
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![iStock-528606286-handshake-partnership-partner-agreement]( "Is Your Biologics CDMO Transparent?")
Transparency and collaboration with a CDMO are vital for reducing risk and protecting IP. Discover four essential practices, from clear communication to IP safeguards, that help build trust.
