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hESC Manufacturing - Webinar Recording (Nov 2011)

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hESC Manufacturing

Organized by the ISCT Commercialization Committee

Chair: Jon Rowley, PhD, Director, Cell Therapy R&D and Process Development Services

Speaker: Ralf Brandenburger, PhD, Director, Process Sciences, Geron Corporation

Steve Oh, MEng, CEng, CSci, MIChemE, Associate Director and Principal Scientist, Bioprocessing Technology Institute, A*STAR.

Key Objectives:

  • What are human embryonic stem cell derived cell therapies?
  • What are the challenges to scalable manufacture of hESC derived cell therapies?
  • What are some of the new approaches to address these challenges?

Development of Scalable Manufacturing Processes for Human Embryonic Stem Cell (hESC) Derived Therapeutics

Ralph Brandenberger, Ph.D.

Director, Process Sciences, Geron Corporation

hESC derived therapeutics offer one of the most promising opportunities in the future of biotechnology development. hESCs have the ability to both proliferate in culture and, under appropriate growth conditions, differentiate into lineage restricted cell types representative of all three primary germ layers: endoderm, mesoderm and ectoderm. As the first hESC derived cell therapies have entered early stage clinical trials, the development of scalable, clinically acceptable and financially viable bioprocesses to enable advanced clinical trials and eventual commercialization has become more important. Several technologies must be actualized to enable the scalable manufacture of hESC-based cell therapies. First, scalable production of hESCs must be developed to produce sufficient starting material for the production of the therapeutic cell population. Second, reproducible, refined, and scalable methods for differentiation of the hESCs to the targeted cell type must be developed. Finally, low cost production systems must be developed to ensure that hESC-based therapeutics can be accessed by all patients. This webinar will review the challenges, and opportunities, to developing scalable manufacturing processes for hESC derived cell therapies, and will present examples of Geron’s approaches to address these challenges.

Pluripotent Stem Cell Processes

Steve Oh, Ph.D.

Principal Scientist, Bioprocessing Technology Institute, A*STAR

The ability of human pluripotent stem cells (hESC and hiPSC) to differentiate to a variety of cell types generates a unique potential for the development of new cell based therapeutics and human based in vitro drug screening and testing. One of the issues that need to be resolved in order to develop these technologies is large scale, suspension stem cell bioprocessing. In this webinar, I will present several topics related to pluripotent stem cell manufacturing such as serum free media development, defined surfaces and different microcarriers for cell expansion and differentiation to human cardiomyocytes and neural stem cells. Cell yields are typically at least 3 times higher and more consistent when generated in the versatile microcarrier system compared to the 2D or embryoid body culture platforms; and the processes require much less manual interventions as the volumes increase. There is the added option of further improvement by optimization and control of environmental parameters.


This product is a downloadable PDF containing a link to the mp4 video recording of this presentation featuring the Power Point slides and audio recording.

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