Cell and Gene 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. 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.

  4. 12-Day Stability Of PRIME-XV T Cell Expansion Supplemented With CTGrade GMP Cytokines 10/17/2025

    Discover how T-cell culture media supplemented with key cytokines can maintain full functionality and support robust expansion for up to 12 days at room temperature.

  5. 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.

  6. Regionalized Filter Supply Chain: Biopharma Supply, Reimagined 10/16/2025

    Discover a regionalized filtration network that delivers consistency, security, and sustainability for biopharma manufacturing—featuring ISO-certified sites, climate-neutral operations, and a broad filter portfolio.

  7. Supply Resiliency For Bioprocessing Amid Global Volatility 10/2/2025

    Build bioprocessing resiliency with strategic supply chain management. Learn to meet quality, compliance, and time-to-market demands amid global volatility with effective sourcing.

  8. Blast Freezing And Thawing For Any Primary Packaging 9/26/2025

    Get high-speed, GMP-compliant blast freezing and thawing for drug substances in any primary packaging. This system seamlessly transfers product to ultra-low storage, maximizing density.

  9. Blast Freezer For Pharmaceuticals: RoSS.BLST 9/26/2025

    RoSS.BLST is a GMP-compatible system for blast freezing & thawing of drug substances. It is suitable for any primary packaging from all manufacturers and allows freezing and thawing within a temperature range of -80°C to +40°C.

  10. Key Considerations For Materials And Components Used In CGT Manufacturing 9/25/2025

    This article sheds light on the complexities and regulatory intricacies of ancillary materials and single-use systems in cell and gene therapy manufacturing.