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On-demand webinar

CGMP-compliant iPSC manufacturing and development of differentiated cells for advanced therapies: strategies and challenges

In this webinar, experts discuss the current state-of-the-art for iPSC generation and differentiation. The presentation also highlights the development of advanced CGMP-compatible protocols for converting these cells into several cell types of therapeutic relevance.

About this webinar

Despite the potential benefits of induced pluripotent stem cells (iPSCs) to differentiate into multiple cell lineages and serve in regenerative medicine and immune cell therapy, CGMP-compatible implementation of the necessary methodologies remains challenging. At the technical level, the methodology to generate functional cell types from iPSCs must display a high degree of robustness, as well as scalability, to comply with the strict CGMP requirements.

In this webinar, experts will discuss the current state-of-the-art for iPSC generation and differentiation. The presentation will also highlight the development of advanced CGMP-compatible protocols for converting these cells into several cell types of therapeutic relevance, including retinal pigment epithelium (RPE), mesenchymal stem cells (MSCs), cardiomyocytes (CMs), and immune natural killer (NK) cells. There will also be discussion on the quality of iPSCs as starting material for clinical use and the development of meaningful assays to assess purity and impurities in the product and to monitor potency.

Key Takeaways

  • Understand the principles and challenges of reprogramming iPSCs and key considerations of their derivation and banking
  • Define CGMP-compliant iPSC manufacturing and improved iPSC differentiation protocols for cell therapies
  • Addressing key quality characteristics and functionality of cells differentiated from iPSCs.

Our speakers

Boris Greber, Ph.D, Head of Research & Development, iPSC, Catalent Cell & Gene Therapy.

Dr Greber is the Head of Research and Development (R&D), iPSC at Catalent Cell & Gene therapy in Europe. He joined Catalent as part of the RheinCell Therapeutics acquisition. He previously served as an independent research group leader at the Max Planck Institute for Molecular Biomedicine (Germany). Dr Greber is internationally recognized with a 15 year track record in basic and applied human iPSC research.

shin kawamata

Shin Kawamata, M.D., Ph.D., CEO, Cyto-Facto Inc., Professor of Science and Technology Dept. Kobe Univ.

Dr. Kawamata studied physics at Kyoto University, Japan (1981) and medicine at the Medical School of Kobe University, Japan (1990) and received his doctorate degree from Kyoto University in pathology (1998). He developed human leukemia mouse models at Systemix Co., Palo Alto USA and Stanford University during his postdoctoral period (1998-2001). Dr. Kawamata became a Chief Scientist and the General Manager of the Cell Processing Facility in the Foundation for Biomedical Research and Innovation (FBRI, NPO) (2002-2014) and Director of R&D Center for Cell Therapy (2015-2023 March). In April 2023, Dr. Kawamata became CEO of Cyto-Facto Inc. His major research fields are stem cell differentiation and cell processing.