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Accelerating Manufacturing for Next Generation hiPSC-Based Clinical Therapies
Human induced pluripotent stem cell (hiPSC)-based therapy is currently at the forefront of technology boom and is advancing at a rapid pace. Generating hiPSCs under current Good Manufacturing Practice (cGMP) conditions, tissue sourcing, testing, and scale of production, are now considered as critical components of both clinical and commercial successes. In this webinar, the presenters will share their experiences of the development and manufacturing of hiPSCs. The expert panel will highlight key considerations for driving clinical and commercial success with hiPSCs as starting materials, including aspects such as their derivation, expansion, and differentiation. The experts will also share strategies that can improve the speed, quality, cost of goods, differentiation, and scaling up of hiPSC-based therapies.

Key learning objectives:

- Learn what key criteria a cell therapy developer should use in selecting starting material for hiPSC generation
- Understand the process development and characterization of hiPSC- derived cell therapies and how to address manufacturing challenges
- Insights into expansion and differentiation of hiPSC in large-scale production.
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James Crutchley, Ph.D.
Senior Process and Analytical Development Manager @Catalent Cell and Gene Therapy
James Crutchley, Ph.D. is a Senior Process and Analytical Development Manager at Catalent Cell and Gene therapy in Europe. In his role, he oversees process and analytical method development activities for internal innovation and client-facing projects for cell therapy. His expertise spans across broad modalities ranging in clinical and commercial scale. James earned his PhD from the University of Nottingham. His thesis was focused on bioprocessing and analytical method automation of hPSC differentiation to generate and utilize cellular models for drug screening. His post-doctoral career involved developing analytical methods and manufacturing processes for hPSCs with specific applications in cell therapy. He progressed his industry career by joining MaSTherCell, which was later acquired by Catalent Cell and Gene Therapy.
Boris Greber, Ph.D.
Head of R&D iPSC/CT @Catalent Cell & Gene Therapy
Boris Greber, Ph.D., is the Head of 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). Boris is internationally recognized with a 15-year track record in basic and applied human iPSC research.
Robert Zweigerdt, Ph.D.
Principal Investigator @Hannover Medical School (MHH)
Robert is a developmental biologist and received training in stem cell research and bioprocessing in academia and in biotechnology companies. Since 2009, he is PI at the “Research Center for Translational Regenerative Medicine“ (REBIRTH) at Hannover Medical School. His group aims at adapting stirred tank bioreactor technologies for the efficient production of hPSC and their progenies to promote the clinical translation of advanced cell therapies. Moreover, his group is investigating basic mechanisms of mesendodermal differentiation and formation of novel Heart Forming Organoids, to provide complex in vitro models of human development and pathology.