Cell Therapy (ATMP) - Process development and GMP manufacturing

Short description

The modules of this course are highly interactive and have a focus on practical implications.

Approximately 50% of the modules contain  practical activities.

The main topics covered are:

• Regulatory framework applied to ATMPs (advanced therapeutic medicinal products)
• Quality controls & documentation for cell based medicinal products
• Manufacturing processes  
• Cell characterization & quality control methods for cell based medicinal products

This course is organized in cooperation with Thermo Fisher Scientific.

Objectives

• Gain understanding of regulatory  guidelines for ATMPs and practical implications thereof
• Learn about the specific characteristics of cells and their manufacturing processes
• Find out more about how quality control methods for cell based medicinal products
• Acquire more knowledge of how to and why transfer processes to close set-up
• Get practical experience in single use technologies
• Gain hands-on experience in cell visualization and cell counting
• Gain practical insights into cell separation, bioreactor culture (rocker) and flow cytometry

Target group

Production support, process development, analytical development or QC technicians as well as researchers of hospitals or translational centers that want to learn more about tools, techniques, regulations and guidelines in cell therapy products manufacturing.