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

Primorigen Biosciences将利用II期SBIR资金推进其新颖的三维系统，通过a)扩大3L生物反应器中iPSC的生产，b)验证生物反应器扩增的iPSC分化成有价值的药物筛选谱系，以及c)验证iPSC的大规模冷冻保存。第一阶段的研究成功地证明了iPSC在新系统中扩展的可行性，与标准的二维培养相比，其额外的好处是大大降低了培养基和劳动力需求。第二期研究将验证上述系统的大规模应用。最终的商业目标是通过解决当前技术和市场对具有成本效益的大规模生产多能干细胞的需求，使干细胞及其衍生物工业化，多能干细胞是将干细胞用于治疗疾病的一个关键障碍

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 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.