Featured Editorial
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Powering Cell Therapies With RNA: A New Code For Engineered Immunity
12/19/2025
RNA is redefining cell therapy engineering—enabling transient, programmable control of immune and stem cells while simplifying manufacturing, improving safety, and accelerating scalable, virus-free workflows.
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Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026
12/16/2025
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.
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What 2025 FDA Warning Letters Tell Us About GMP Compliance
12/15/2025
This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.
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Why RNA Tech Transfer Is So Hard — And How the Field Can Fix It
12/11/2025
A closer look at why RNA tech transfer remains one of the field’s toughest bottlenecks — and the practical steps developers and CDMOs can take to finally streamline the path to GMP.
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Making Personalized Cancer Vaccines Reality: The Manufacturing Challenge Ahead
12/5/2025
Personalized cancer vaccines are becoming feasible, but scaling fast, affordable, data-driven manufacturing is the central challenge to bringing these individualized therapies to more patients.
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Strained Manufacturing, Complexity Stymie In Vivo Progress
12/4/2025
Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.
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To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem
12/4/2025
The choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.
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RNA's Evolutionary Logic Is Quietly Rewriting The Future Of Therapeutics: A Conversation With Ahmet Berkyurek
12/3/2025
RNA’s adaptive logic is reshaping how therapies are designed. Ahmet Berkyurek explains why embracing evolution—not engineering against it—may unlock the next generation of RNA medicines.
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Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next Chapter
11/25/2025
Now, I cannot claim that I or any of the panelists at CASSS have or had access to a real crystal ball that will show us the future. However, what did come through these discussions loud and clear is that the future of our industry must include “balance.” Here, I’ll unpack a few ways the theme of “balance” presented itself — and no doubt will continue to present itself in the future — as well as how the panelists see us achieving this necessary balance.
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Rethinking The "3:1 Rule" In LNP Production
11/21/2025
A new two-step, ideal-mixing strategy from MIT researchers shows how operating briefly in unstable regions of LNP assembly can unlock precise control of particle size and shape—advancing next-gen RNA manufacturing.