ATMP Manufacturing – Cell and Gene Therapies

• 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

Learner Benefits:

• Gain a clear understanding of Advanced Therapy Medicinal Products, including the differences between cell and gene therapies and how they differ from traditional biologics.

• Learn about the key steps and challenges involved in the manufacturing processes of autologous and allogeneic cell therapies, enhancing your ability to navigate these cutting-edge technologies.

• Understand the hurdles faced in the production of cell and gene therapies, including scale-up limitations, cost concerns, and contamination risks, and explore potential strategies to overcome these challenges.

• Explore the future of ATMP manufacturing, focusing on automation and closed processing, and understand how these innovations will shape the scalability and commercial viability of cell and gene therapies.

• Gain insight into the personalized nature of cell and gene therapies, learning how these therapies offer precise treatment options for various diseases, potentially leading to cures rather than mere symptom management.

    Animations
   Voice Over
    Knowledge Checks
    Assessments
   SCORM/AICC compatible
    Full Screen