Cell and Gene Manufacturing and Logistics

  1. New Guide Aims To Build Robust Framework For Digital Validation Tools 10/22/2025

    The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

  2. Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms 10/22/2025

    The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.

  3. The 9 Fastest-Growing Outsourcing Segments 10/21/2025

    Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.

  4. Takeda Reimagines Biopharma Quality For The Digital Age 10/21/2025

    Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it.

  5. How Lipid Nanoparticles Enable Next-Gen Delivery 10/20/2025

    Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.

  6. Inside The Operational Hurdles Of Advanced Therapy Medicinal Products 10/20/2025

    Despite rapid approvals, ATMP patient access is limited by operational bottlenecks. Successfully delivering these therapies demands tightly synchronized logistics and resilient contingency planning.

  7. Predicting The Performance Of Perfusion Media In A Continuous Bioreactor 10/17/2025

    Small-scale perfusion-mimic models can effectively predict media performance in continuous bioreactors to help optimize cell density, productivity, and scalability for CHO cell lines.

  8. Resin Guide: A Trusted Resource for Biotherapeutic Purification 10/17/2025

    Trace the evolution of chromatography resins and explore technologies designed for high-resolution purification, from ion exchange to mixed-mode formats.

  9. 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing 10/17/2025

    Research Manager Mathini Ilancheran explores the effects of U.S. drug tariffs on global supply chains, multinational pharma firms, and critical partners across drug development.

  10. Virus Reduction And Impurity Removal 10/16/2025

    Examine a DOE-based study that reveals how buffer conditions impact virus and impurity clearance using a mixed-mode resin, as well as gain practical guidance for optimizing downstream purification.