PRIMORIGEN BIOSCIENCES INC. — Department of Health and Human Services SBIR Phase II: DESCRIPTION (provided by applicant): Primorigen Biosciences (R) Abstract Primorigen Biosci

Description

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.