INSIGHTS ON CELL & GENE THERAPY LOGISTICS

  • Refrigerated Transport For Gene Therapy Products — Exploring The Pros And Cons
    Refrigerated Transport For Gene Therapy Products — Exploring The Pros And Cons

    The viability and cell count of immunotherapies are extremely sensitive to temperature. Additionally, these products demonstrate reactivity to cooling and thawing rates between room temperature and refrigerated/frozen temperatures.1 The same sensitivity applies to apheresis material, which is susceptible to failure if not fully protected against temperature fluctuations.

  • Cell Therapy Manufacturing: The Supply Chain Challenge
    Cell Therapy Manufacturing: The Supply Chain Challenge

    Overcoming the challenges of manufacturing and administering a complex product to any patient is critical for delivering cell therapies. Here two industry experts provide practical advice on strategies to meet supply chain challenges.

  • 4 Strategies For Success In The CAR-T 2.0 Marketplace
    4 Strategies For Success In The CAR-T 2.0 Marketplace

    As the second wave of CAR-T therapies begins coming to market in the next five years, their manufacturers will need to anticipate and prepare to address many of the same commercial challenges as their predecessors, as well as several additional ones.

  • Cryogenic Transport For Gene Therapy Products — The Pros And Cons
    Cryogenic Transport For Gene Therapy Products — The Pros And Cons

    Temperature-controlled packages used for the transport of gene therapy products use a combination of thermal insulators or thermoregulators to decrease the heat transfer rate from outside of the shipper to the inside. The overall design of the package is pivotal in achieving the minimal heat transfer rate.

  • Is A Rapid Cooling Step Needed When Freezing Cells For Cryopreservation?
    Is A Rapid Cooling Step Needed When Freezing Cells For Cryopreservation?

    Successful cell cryopreservation requires a controlled cooling rate. Cooling too rapidly or too slowly will lead to a poorer outcome. This study shows comparable results when freezing cells with or without a rapid-cooling nucleation step.

  • Freezing Cellular Raw Materials For Cell Therapy Production
    Freezing Cellular Raw Materials For Cell Therapy Production

    Key Biologics is harnessing new freezing technology to help deliver the future of medicine. Digitally enabled cryogenic cold chain technology can now deliver the raw materials needed to manufacture cellular therapies.

  • Big Data And AI In Pharma Development And Manufacturing: An Inside Look
    Big Data And AI In Pharma Development And Manufacturing: An Inside Look

    Artificial intelligence and Big Data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs, and to better design new drugs.

  • Recalibrating The Supply Chain For Allogeneic Cell Therapies
    Recalibrating The Supply Chain For Allogeneic Cell Therapies

    In November 2018, I wrote an article about establishing a supply chain for autologous cell therapies — those formulated using a patient’s own cells. This partner piece highlights considerations that need to be taken into account when developing a commercialization and supply chain strategy for allogeneic cell therapies.

  • Cell Therapy Logistics
    Cell Therapy Logistics

    Having a sound logistics strategy to ensure that a living drug is delivered to the right patient at the right time, location, and temperature is essential to patient safety and product effectiveness.

  • Sneak Peek: The Unique Challenges Of Cell And Gene Supply Chains
    Sneak Peek: The Unique Challenges Of Cell And Gene Supply Chains

    Two of the field’s most valuable luminaries representing both academia and industry — Dr. Bruce Levine and Simon Ellison, ISCT Commercialization Committee — discuss determining how CMOs can and should successfully manage cell and gene therapy supply chains.

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