Cell and Gene Logistics

  1. A Case For Paying Allogeneic Cell Therapy Product Donors 5/9/2025

    The debate over whether to pay donors for cell therapy starting materials comes down to four areas of disagreement: altruism, availability, ethics, and safety.

  2. From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025 5/7/2025

    The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.

  3. Comprehensive, Integrated BioServices 5/2/2025

    Discover more about optimized storage, packing, labeling, and global distribution, seamlessly integrated for your supply chain. Simplify complexity and enhance the reliability of your supply chain.

  4. 8 Ways To Drive Resilience In Oncology Drug Supply Chains 5/2/2025

    From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality.

  5. How IntegriCell™ Services In Belgium Ensure Cell Viability, Supply Chain Integrity 4/28/2025

    he effectiveness of cell-based therapies hinges on preserving cell viability, stability, and consistency. However, inconsistencies in cryopreservation methods have undermined therapeutic success.

  6. How BioServices Centers In France Enable Efficiency And Scalability 4/28/2025

    To support the growing demands of the ATMP industry, it's essential to leverage integrated biostorage, sample management, and regulatory solutions, and we are committed to enhancing these capabilities.

  7. PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand 4/24/2025

    Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.

  8. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

  9. Deep Interpretation Of GMP Product Quality 4/23/2025

    Explore the critical aspects of GMP-grade raw materials in cell and gene therapy manufacturing, including contamination control, aseptic strategies, quality systems, supply chain security, and regulatory compliance.

  10. Raw Materials Considerations When Manufacturing CGTs And Other Biologics 4/23/2025

    Discover key considerations for qualifying GMP raw materials in cell and gene therapy manufacturing, emphasizing quality control, supplier selection, and regulatory compliance to ensure therapeutic safety and efficacy.