Webinar: Manufacturing Human iPSCs and Derivatives under cGMPs for Clinical Applications

Fundamental and translational scientists from academia and industry who attend this webinar will learn about:

  • The Cedars-Sinai Biomanufacturing Center: Enabling early-phase clinical trials by addressing bioprocess bottlenecks in large-scale cell and gene vector manufacturing under current Good Manufacturing Practices (cGMPs)
  • Manufacturing human induced pluripotent stem cells (iPSCs) under cGMPs, with consideration of donor selection criteria, cell sources, reprogramming methods, genetic stability, and other Critical Quality Attributes (CQAs)
  • Regulatory requirements for cell therapy products, including cGMPs
  • Process development for cell expansion and scale-up
  • A human iPSC platform facilitating large consortium multi-omics studies, mechanistic disease modeling, drug discovery, and space research
  • The biopharmaceutical clinical research and development process for Advanced Therapy Medicinal Products (ATMPs), including human cells
  • Creating iPSC human leukocyte antigen (HLA) haplobanks
  • Differentiating iPSCs into target cell types under cGMPs
  • Developing target product profiles (TPPs) for differentiated cell types

Featured Speakers

Dhruv Sareen, PhD

Executive Director

Cedars-Sinai Biomanufacturing Center

Dhruv Sareen, PhD, is the founding director of the (iPSC) Core Facility at the Cedars-Sinai Medical Center and founding executive director of the new Cedars-Sinai Biomanufacturing Center. Dr. Sareen has extensive experience with human induced pluripotent stem cell (iPSC)-based disease models, cell signaling, mechanistic drug discovery, process development of early research discoveries, and optimizing cGMP-compatible stem cell therapies.


© 2021 Questex LLC, All right reserved.

685 Third Avenue, 21st Floor New York, NY 10017

Reproduction in whole or part is prohibited.