Organized by the ISCT Commercialization Committee
Chair: Jon Rowley, PhD, Director, Cell Therapy R&D and
Process Development Services
Brandenburger, PhD, Director, Process Sciences, Geron
Steve Oh, MEng, CEng, CSci, MIChemE,
Associate Director and Principal Scientist, Bioprocessing Technology Institute,
- What are human embryonic stem cell derived cell therapies?
- What are the challenges to scalable manufacture of hESC derived cell
- 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
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,
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
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.