A Novel System for Mass Production of iPS Cells

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43GM096669-01
Agency Tracking Number: R43GM096669
Amount: $343,865.00
Phase: Phase I
Program: SBIR
Awards Year: 2011
Solicitation Year: 2011
Solicitation Topic Code: NIGMS
Solicitation Number: PA10-050
Small Business Information
DUNS: 782932177
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (608) 441-8331
Business Contact
Phone: (608) 441-8334
Email: Chuck.Oehler@primorigen.com
Research Institution
DESCRIPTION (provided by applicant): Primorigen Biosciences LLC SBIR Project Abstract Primorigen will use SBIR funds to develop and validate a microcarrier-based cell culture system for selection, scale-up and feeder-free mass production of iPS cells, based on Primorigen's proprietary pluripotent stem cell attachment factor (StemCadhere ) for direct physical selection and propagation of iPSC. Phase I studies will define coupling chemistry that optimizes E-cadherin mediated cell adhesion to StemCadhere -coated microcarriers, analyze iPSC attachment efficiency and propagation on the StemCadhere -coated microcarriers, analyze the utility of StemCadhere-coated microcarriers for direct physical selection of newly induced iPS cells, and compare performance of cryopreserved iPSC on StemCadhere -coated microcarriers with Matrigel-coated microcarriers. This work will provide the foundation for Phase II studies, which will investigate production of differentiated cells directly on the microcarriers. Similar methods will be used to test and select cellular adhesion molecules specific for each germ layer (ectoderm, mesoderm and endoderm), and for a limited number of terminally differentiated lineages such as hepatocytes, cardiomyocytes, and hematopoietic cells. The initial commercialized products will be a) ready-to-use (cryopreserved) iPS cells attached to the microcarriers, ready for addition of differentiation factors and downstream protocols; and b) a new application for attachment factors coupled to microcarriers thatPrimorigen can market at large to pharmaceutical and biotechnology firms engaged in differentiated cell production from iPS. PUBLIC HEALTH RELEVANCE: Primorigen Biosciences LLC SBIR Project Narrative Current methods for production of iPS cells require labor intensive manual culturing steps, frequent feeding of cultures, and inclusion of drug-selectable resistance markers to achieve purification of iPS from non-induced parental cells (such as foreskin fibroblasts). To fulfill the promise of iPS cellsas a source for cellular therapies and differentiated cells for pharmaceutical development, it is mandatory to avoid the use of lentiviral vectors and other agents capable of genomic integration, which precludes the use of integrated drug-resistance markers for iPS selection. In addition, to decrease variability in production lots, it is desirable to automate as much of the culture as possible, while maintaining the proliferation and pluripotency of the iPS cells. Primorigen's SBIR proposal will address this need by developing a comprehensive, integrated solution for selection and mass production of iPS cells by taking advantage of Primorigen's proprietary stem cell attachment factor for feeder-free propagation of iPS cells in microcarrier suspension culture.

* Information listed above is at the time of submission. *

Agency Micro-sites

SBA logo
Department of Agriculture logo
Department of Commerce logo
Department of Defense logo
Department of Education logo
Department of Energy logo
Department of Health and Human Services logo
Department of Homeland Security logo
Department of Transportation logo
Environmental Protection Agency logo
National Aeronautics and Space Administration logo
National Science Foundation logo
US Flag An Official Website of the United States Government