Expert Insights on GCT Cold Chain Logistics

  1. Solving The Leukopak Supply Chain Issue With Cryopreservation 11/25/2024

    Allogeneic cell therapy developers report an alarming number of starting materials arrive at the wrong temperatures, late, or fail to arrive altogether.

  2. Is The BIOSECURE Act The First Real Step Toward Reshoring? 11/22/2024

    The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?

  3. Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why 11/19/2024

    The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.

  4. 3 Focus Areas To Transition From Clinical To Commercial Readiness 11/12/2024

    Transitioning from clinical-stage operations to commercial readiness is a multifaceted process. Establish compliant and robust distribution systems by focusing on these three areas.

  5. A Comprehensive Guide For Supplier Quality Agreements 10/29/2024

    This overview of SQAs includes a handy matrix template, which is useful for determining who is responsible for managing specific responsibilities.

  6. Cell & Gene Therapies: Avoid This Common Pitfall In Supply Chain Planning 10/24/2024

    BioPhorum members propose a Design for Supply model for cell and gene therapy supply chain planning. Don't let it take a backseat until the later stages of the product life cycle.

  7. What's Next After FDA's DSCSA Extension? 10/18/2024

    Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.

  8. Data Quality Issues At The Heart Of FDA's DSCSA Troubles 10/18/2024

    Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.

  9. What's In The Leukopak Matters For Cell Therapy Manufacturing 10/11/2024

    Advanced cell-based therapies are impossible without high-quality leukopaks from high-quality donors.

  10. How Elixirgen Manufactures Hematopoietic Stem Cells At The Bedside 10/9/2024

    The company uses a mobile manufacturing system to produce autologous stem cell therapy for patients with dyskeratosis congenita and other telomere biology disorders.