ATMP Manufacturing - Cell and Gene Therapies
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
