Course Outline

Hands-on Laboratory Bootcamp for Cell Therapy Biomanufacturing

Day 1 (7 hrs, including introduction, break, lunch, and wrap-up)

  • Introduction to the Laboratory Environment (3 hrs)
  • Data Management and Reporting (3 hrs)

Learning Outcome:

    • Apply laboratory safety, PEE, and ergonomics for working in the lab.
    • Become aware of the process for handling and reporting spills and injuries.
    • Understand how to operate essential laboratory equipment (pipettes, biological safety cabinets, centrifuge, etc.)
    • Apply proper aseptic techniques when handling biohazard materials in the lab.
    • Report using GLP best practices.
    • Learn to track samples, reagents, and data.
    • Develop a basic understanding of GLP standards. 

Day 2 (7 hrs, including break, lunch, and wrap-up)

  • Basics of Cell Product Testing (3 hrs)
  • Mammalian Cell Culture (3 hrs)

Learning Outcome:

    • Demonstrate knowledge of sterility, mycoplasma, and endotoxin testing.
    • Understand manual and automated cell counting.
    • Demonstrate knowledge of documentation using GLP practices.
    • Evaluate post-thaw mammalian cells' quality, such as cell viability and recovery.
    • Set up mammalian cell culture (e.g. T cells and MSCs).

Day 3 (7 hrs, including break, lunch, and wrap-up)

  • Maintain Cell Culture (continued) (3 hrs)
  • Harvest and Cyropreservation (3 hrs)

Learning Outcome:

    • Visually inspect MSCs and T cells under the microscope.
    • Maintain and passage mammalian cells.
    • Calculate appropriate cell densities and prepare reagents for expansion.
    • Perform cell counting and viability assessment.
    • Harvest and cryopreserve mammalian cells.

Day 4 (7 hrs, including break, lunch, and wrap-up)

  • Cell Manufacturing (3 hrs)
  • Cell Manufacturing (3 hrs)

Learning Outcome:

    • Overview of GLP/GMP-like PPE and lab overview.
    • Develop an understanding of small to large-scale cell manufacturing instruments (e.g., PBS, wave, hollow fiber, Terumo, quantum bioreactors.)
    • Hands-on training with vertical-wheel bioreactors.

Day 5 (7 hrs, including break, lunch, and wrap-up)

  • Characterization Assays (7 hrs)

Learning Outcome:

    • Evaluate and characterize cell products (such as apoptosis, ELISA.)
    • Data collection and analysis.