A Novel System for Mass Production of iPS Cells

Award Information
Agency:
Department of Health and Human Services
Amount:
$343,865.00
Program:
SBIR
Contract:
1R43GM096669-01
Solitcitation Year:
2011
Solicitation Number:
PA10-050
Branch:
N/A
Award Year:
2011
Phase:
Phase I
Agency Tracking Number:
R43GM096669
Solicitation Topic Code:
NIGMS
Small Business Information
PRIMORIGEN BIOSCIENCES, INC.
510 CHARMANY DRIVE, MADISON, WI, -
Hubzone Owned:
N
Woman Owned:
N
Socially and Economically Disadvantaged:
N
Duns:
782932177
Principal Investigator
 SCOTT MONSMA
 (608) 441-8331
 scott.monsma@primorigen.com
Business Contact
 CHUCK OEHLER
Phone: (608) 441-8334
Email: Chuck.Oehler@primorigen.com
Research Institution
 Stub
Abstract
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.

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