Industry Insights

  1. Easing Autologous Cell Collection, Automating Manufacturing 1/22/2025

    To circumvent the challenges of leukapheresis, CellProthera developed a novel method for collecting therapeutic stem cells from whole blood. CSO Ibon Garitaonandia, Ph.D., discusses the company's mission to streamline manufacturing.

  2. Upgrading The Vial/Vein-To-Vein Process With Enterprise-Level Digital Infrastructure 1/21/2025

    The cell and gene therapy's value chain has come to be known as the vein-to-vein/vial-to-vein process. Enterprise-level digital infrastructure can address the sector's challenges in a variety of ways.

  3. 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.

  4. Cell & Gene Therapy Manufacturing: Considerations For Early-Stage Companies 1/17/2025

    Key considerations for early-stage cell and gene therapy companies include whether to develop and manufacture internally vs. externally, locally vs. not, and how to choose a CDMO.

  5. Building Frameworks To Support Complex Therapy Manufacturing 1/16/2025

    To make its clinical product, CLBR001+SWI019, the Calibr-Skaggs Institute for Innovative Medicines relies on a complex network of contractors from around the globe.

  6. Audit Readiness For Cell & Gene Therapy Companies 1/16/2025

    Cell & gene therapy companies are required by regulation to qualify sites performing all the steps and methods as part of their manufacturing processes. 

  7. New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings 1/15/2025

    To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.

  8. Host Cell DNA Impurities: A Unique Challenge For rAAV 1/10/2025

    The potential safety impact of residual hcDNA remains largely unknown, but researchers at UCB are investigating to learn more and mitigate if necessary.

  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. CTMC's 2025 Cell Therapy Manufacturing Outlook 1/10/2025

    CEO Jason Bock looks back on milestones of 2024, namely an approved TIL for melanoma, and explains how it sets the stage for this year.