Our Expert Network

  1. How Automation And AI Can Accelerate Clinical Research And Outbreak Response 2/18/2025

    Explore AI-driven automation and organ-on-a-chip technology to accelerate infectious disease research, enhancing assay efficiency, and improving vaccine and therapeutic development for emerging global health threats.

  2. FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products 2/14/2025

    The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.

  3. FDA Finalizes Guidance On The Advanced Manufacturing Technologies Designation Program 2/10/2025

    The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft.

  4. mRNA Empowering Engineered In Vivo Cell Therapies 1/21/2025

    Recent advances in non-viral delivery technologies have enabled a first generation of genetically modified immune cells in vivo. Deploying these new approaches can address challenges with traditional ex vivo CAR-T cell therapy.

  5. Tune Therapeutics' 2025 Epigenome Editing Outlook 1/10/2025

    Chief Scientific Officer Derek Jantz talks about recent key innovations in gene therapy and RNA technology while considering what milestones we might see in 2025.

  6. RNA Therapeutics As We Enter 2025: Looking Beyond The Horizon Of First-Generation Success 1/9/2025

    As we enter 2025, RNA therapeutics are poised to command significant attention from industry leaders as well as emerging players.

  7. 2025 Forecast For Advanced Therapies 1/8/2025

    As we reflect on the lessons from 2024, it’s time to consider what 2025 may hold for the industry. Special attention is given to oligos, mRNA, cell therapies, and AAV.

  8. Go From Batch To Continuous RNA Purification With mAb Equipment And QBD 12/30/2024

    University of Sheffield researchers developed a novel method purify polyadenylated mRNA continuously, which stands to improve productivity and efficiency.

  9. FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics 12/11/2024

    FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.

  10. Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides? 12/10/2024

    Oligonucleotides and peptides require precise, scalable, and compliant production. CDMOs are integrating AI-driven technologies to answer the call. Many of these technologies are notable for specific needs.