Manufacturing GMP-compliant iPSCs in closed and open systems
Human pluripotent stem cells (PSCs) and their derivatives hold great potential in regenerative cell therapies, and recently have been used in a number of clinical trials targeting various diseases.
In this webinar, Dr. Dhruv Sareen (Executive Director, Cedars-Sinai Biomanufacturing Center) will introduce the Cedars-Sinai Biomanufacturing Center, a leading center of excellence in the manufacturing of induced pluripotent stem cells (iPSCs) and cell and gene therapies. He will describe the manufacturing of human iPSCs under current Good Manufacturing Practices (cGMPs). Consideration will be provided to donor selection criteria, cell sources, reprogramming methods, genetic stability, cell banking process flows, expansion in open and closed systems, specifications, and related Critical Quality Attributes (CQAs). Afterwards, Dr. Chao Sheng (Product Manager, Regenerative Medicine, Miltenyi Biotec) will introduce the established workflow from Miltenyi Biotec for GMP-compliant human PSC expansion using the CliniMACS Prodigy® Adherent Cell Culture process and the iPS-Brew GMP Medium.
- Addressing bioprocess bottlenecks in large-scale iPSC and differentiated cell manufacturing with current Good Manufacturing Practices (cGMPs), considering the impact of cell source, reprogramming methods, and cell expansion on genetic stability.
- Developing efficient iPSC banking process flows, cell expansion, specifications, and related Critical Quality Attributes (CQAs).
- How to realize GMP-compliant PSC expansion using the closed and automated CliniMACS Prodigy.