Synthemax surface, a new synthetic matrix for growing human embryonic stem cells (hESCs)in a scalable manner has been developed by under a collaboration and license agreement between Geron Corporation announced that Corning Incorporated.
Synthetic growth surfaces enable readily scalable and cost-effective production of undifferentiated hESCs and their differentiated therapeutic cells.
Biological surface coatings are expensive to produce, have lot-to-lot variability, and are subject to costly testing to ensure that they are pathogen-free.
Biological materials present a challenge for manufacturing human embryonic stem cells-derived products at scales required for therapeutic applications.
Geron and Corning have been working together to develop synthetic surface matrices to enhance the scalability of human embryonic stem cells-derived product manufacturing. The Corning Synthemax surface is the first such product to be commercialized.
Human embryonic stem cells express telomerase and have the capacity for indefinite replication in the undifferentiated state while retaining the potential to develop into all the cell types of the human body (pluripotency).
With these properties, human embryonic stem cells are the ideal starting material for large-scale production of cell therapies. To date, hESCs have been grown in complex culture systems that use biological materials, such as culture vessels with biological surface coatings.
“The synthetic growth matrix technology developed in our collaboration with Corning is an enabling platform to be used by Geron in producing new cell therapies for patients with degenerative diseases,” stated Jane S Lebkowski, Geron’s senior vice president and chief scientific officer, regenerative medicine.
This technology allows for more consistent, reliable and cost-effective manufacturing of human embryonic stem cells-derived products, he added.
The Synthemax surface supports the long-term propagation of hESCs cultured in a defined, xeno-free medium, while maintaining stable proliferation rates; characteristic phenotypic marker profile of the undifferentiated state; normal karyotype; and pluripotency.
Geron and Corning scientists presented data showing robust hESC growth and differentiation on the Synthemax surface at the September 2009 World Stem Cell Summit.
The laboratory products using the Synthemax surface and other synthetic surface matrices developed under the collaboration between Geron and Corning will be commercialized by Corning. Geron will receive a royalty on product sales and has exclusive rights to use the synthetic surface matrices, including the Synthemax surface, in the manufacturing of certain therapeutic products.
Currently, Corning’s 6-well plate with the Synthemax surface is available in North America.
Corning Incorporated is the world leader in specialty glass and ceramics.
Geron is developing biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes.