PROCESS DEVELOPMENT LAB
Magdi Elsallab, MD, PhD
Director of the Process Development Lab
Magdi grew up in Mansoura, Egypt, where he also attended college and medical school. After that, he moved to Berlin, Germany, for his Ph.D. in regenerative therapies. Prior to joining the Maus lab, Magdi held a number of positions in good manufacturing practice (GMP) facilities, including production manager and regulatory affairs specialist. He is interested in process development, manufacturing, and the regulation of cell and gene therapies. Currently, he is working on the distributed manufacturing of CAR T cells and the process development of exciting new CAR T cell innovations. In his free time, Magdi enjoys photography, cooking, and drumming.
Mission
The Process Development (PD) lab delivers advanced manufacturing and control solutions to seamlessly transition cell therapy products from discovery to clinical applications.
Overview
The PD Laboratory serves as a translational platform within the cellular immunotherapy program, bridging laboratory discoveries and clinical applications. Equipped with state-of-the-art technology, the lab focuses on developing, optimizing, and scaling up manufacturing processes to meet regulatory quality standards, preparing them for clinical studies. Additionally, the lab explores innovative methods to increase process capacity, reduce costs, improve quality, and ensure the safety of cellular immunotherapies.
Laboratory Assays
Available Technologies
- Automated cell processing platforms
- Clinical-grade magnetic cell sorting
- Large-scale expansion of immune cells (open and closed systems)
- Viral and non-viral gene modification
- Large-scale genome editing
- IVD-grade multicolor flow cytometry
- IVD-grade hematology analyzer
Available Solutions
- Manufacturing process design and optimization
- Development of product specifications
- Development and optimization of release assays
- Product formulation development
- IND and regulatory support