Our Expert Network

  1. Understanding The New U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies' 3/5/2025

    The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31.

  2. Tessera Therapeutics Advances In Vivo Gene Therapy For SCD 2/24/2025

    Tessera Therapeutics' CSO, Michael Holmes, Ph.D., shares information on the company's Gene Writers for sickle cell disease (SCD) and how their work has garnered investment from of the Bill & Melinda Gates Foundation to support their efforts.

  3. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

    The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.

  4. What Do We (Really) Know About DNA Quality For In Vitro Transcription? 2/19/2025

    Gene therapies and nucleic acid medicines are dependent upon a starting DNA template that defines the protein or antigen. The sequence of this template DNA being correct is critical.

  5. 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.

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 FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products 2/14/2025

    The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025.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

  7. 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.

  8. 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.

  9. 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.

  10. 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.