Our Expert Network
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Designing mRNA For The Next Generation Of Therapeutics
1/23/2026
mRNA’s next leap goes beyond vaccines. This piece explores how tuning sequence design, structure, and longevity enables controlled protein expression for cancer, rare disease, and regenerative uses.
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The Great Cell Therapy Reset: Solving The Industrial Math Of Living Drugs
1/15/2026
The cell therapy sector is experiencing a paradigm shift in manufacturing: from bioreactor (ex vivo) to body (in vivo).
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Oligonucleotide Therapeutics At Scale: Bottlenecks, Breakthroughs, And What Comes Next
1/9/2026
Oligonucleotide therapies have proven clinical value, but scaling beyond rare disease remains hard. William Soliman, Ph.D., BCMAS, breaks down the manufacturing, delivery, and CMC realities shaping what comes next.
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In Vivo LNP-Engineered Cytokine-Armored CAR Cells For Solid Tumors
12/23/2025
By injecting lipid-based nanoparticles encapsulating mRNA and encoding the CAR directly into the bloodstream, developers can effectively reprogram the patient's own immune cells in situ.
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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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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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Four Reasons You Should Choose Lyophilization for Your Next Project
12/10/2025
Lyophilization 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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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.