Containment Considerations for the Cryopreservation of Cell and Gene Therapies

Containment Considerations for the Cryopreservation of Cell and Gene Therapies

07/15/2020, 11:15 AM - 12:00 PM

Stage 3, Booth 1877, Exhibit Hall
Language:
English
The commercialization of cells and nucleic acids for therapeutic use drives a critical need for the refinement of containment and storage procedures to ensure drug product integrity is maintained until administration to the patient. Development of these advanced therapies often begins in an academic setting and is then translated through the clinic into a product ready for GMP manufacture. Along with the product, minimally-controlled processes using research grade consumables are also transferred and are often not revisited until most drug product characterization has been completed. This can give rise to costly changes later, as product handling and storage can have a direct impact on its quality characteristics. On this journey from bench to bedside it is vital that the processes and equipment used are similarly translated to meet the needs of a therapeutic. Here, we identify aspects of containment and storage that can aid in development of advanced therapies if considered early.

Contributors

  • Crystal Kraft, PhD

    Speaker

    Senior Scientific Lead, Advanced Therapies

    West Pharmaceutical Services

Objective

  1. Objective 1. Articulate fundamental differences between cell and nucleic acid handling and storage processes in academic and therapeutic applications. 2. Identify critical elements of advanced therapy containment and storage with supporting examples and data. 3. Advise on practices that can be adopted early on in advanced therapy development that could help to mitigate risk later.

Type of Session

  1. Type of Session
    Session

Categories

  1. Track
    Processing/Manufacturing

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