Our Expert Network

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.