OUTSOURCING ARTICLES
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The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational Friction
Scientific breakthroughs may spark innovation, but operational excellence ultimately determines which advanced therapies reach patients.
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RNA Therapeutics: Why CMC Strategy Will Define The Next Decade
As 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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How Informal FDA Feedback Is Quietly Driving RNA Capital Allocation
Subtle 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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2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture Trends
As 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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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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Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026
Here, 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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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ISO 21973 defines global best practices for transporting cell and gene therapies, ensuring safety, quality, and consistency across complex supply chains vital to patient care.
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Ensure seamless access to European clinical trials and markets with GMP-compliant logistics, regulatory support, and risk mitigation to protect the integrity of your advanced therapies.
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Fragmented pre‑clinical supply chains create avoidable delays and risks; unifying cryopreservation, logistics, and storage early improves consistency, reduces operational gaps, and supports smoother progression into clinical phases.
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In a landscape where speed, quality, and trust are inseparable, choosing a CRO that shares your ambition is not optional; it is essential to survival and success.
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Automated, closed cryo‑processing of leukapheresis preserves cell quality and functionality, enabling flexible, reproducible starting material for both autologous and allogeneic CAR‑T manufacturing.
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Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.