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 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 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.