BPU-1115 (Premium Lesson). This e-Lesson is designed for personnel who require an overview of the nature and function of cell and gene therapy products, their modes of manufacture (with a particular focus on autologous and allogeneic therapies), and the associated technical challenges and regulatory requirements.


  • Category: Biopharma Processes and Equipment

Description

After completing this e-Lesson you will be able to:

  • Define "Advanced Therapy Medicinal Product" (ATMP)
  • Explain the difference between ATMPs and 'traditional' biopharmaceutical products
  • Explain the difference between gene and cell therapies
  • Describe the biological functionality of cell therapies
  • Describe the biological functionality of gene therapies
  • Distinguish between autologous and allogeneic therapeutic approaches
  • List the main steps in manufacturing autologous therapies
  • List the main steps involved in manufacturing allogeneic therapies
  • Describe the challenges associated with ATMP manufacturing, and in general terms how these challenges might be overcome