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A Novel 3-D System for Cost-Effective Industrial Production of Pluripotent Cells

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2013 / SBIR
Agency Tracking Number:
R44GM096669
Solicitation Year:
2013
Solicitation Topic Code:
NIGMS
Solicitation Number:
PA12-088
Small Business Information
PRIMORIGEN BIOSCIENCES, INC.
510 CHARMANY DRIVE MADISON, WI -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2013
Title: A Novel 3-D System for Cost-Effective Industrial Production of Pluripotent Cells
Agency: HHS
Contract: 2R44GM096669-02
Award Amount: $1,236,983.00
 

Abstract:

DESCRIPTION (provided by applicant): Primorigen Biosciences (R) Abstract Primorigen Biosciences will use Phase II SBIR funds to advance its novel, 3-dimensional system for robust expansion of induced pluripotent stem cells (iPSCs) by a) scaling up iPSC production in 3L bioreactors, b) validating the bioreactor-expanded iPSCs for differentiatation into lineages of value for pharmaceutical drug screening, and c) validating large-scale cryopreservation of the iPSCs. Phase I studies successfully demonstrated feasibility of iPSC expansion in the new system, with the added benefits of substantially lowering media and labor requirements versus standard 2-dimensional culture. Phase II studies will validate the system for larger scale applications as described above.The ultimate commercial goals are to enable industrialization of stem cells and their derivatives by addressing the current technical and market need for cost-effective large scale production of pluripotent stem cells, a key barrier to the use stem cellsfor widespread drug screening and clinical therapeutics. To ensure utility for both applications, Phase II studies will continue the work initiated in Phase I to make the system xeno-free and adapatable for ultimate GMP production. The initial productionapplications will be targeted to companies requiring large quantities of phenotypically relevant cell types for drug discovery. Longer term, the system's paradigm-changing efficiency and scalability will be adapted to produce clinical-grade therapeutic cells derived from stem-cells. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Primorigen Biosciences(R) Project Narrative To fulfill the promise of iPS cells as a source for cellular therapies and differentiated cells for pharmaceutical drug evelopment, the market demands cost-effective and scalable methods for large-scale iPSC production. To minimize batch-to-batch variability, the culture process should be automated to the maximum extent while maintaining the proliferation and pluripotency of the iPS cells. Primorigen's SBIR proposal will address these needs by developing a comprehensive, integrated solution for feeder-free, xeno-free, three-dimensional mass production of iPS cells.

Principal Investigator:

Bradley H. Garcia
608-628-5189
brad.garcia@primorigen.com

Business Contact:

Chuck Oehler
608-441-8332
chuck.oehler@primorigen.com
Small Business Information at Submission:

PRIMORIGEN BIOSCIENCES, INC.
510 CHARMANY DRIVE MADISON, WI -

EIN/Tax ID: 101096882
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No