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 cells for 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 production applications 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

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44GM096669-03
Application #
8636028
Study Section
Special Emphasis Panel (ZRG1-IMST-J (15))
Program Officer
Maas, Stefan
Project Start
2011-04-01
Project End
2015-02-28
Budget Start
2014-03-01
Budget End
2015-02-28
Support Year
3
Fiscal Year
2014
Total Cost
$671,283
Indirect Cost
Name
Primorigen Biosciences, Inc.
Department
Type
DUNS #
782932177
City
Madison
State
WI
Country
United States
Zip Code
53719