Palo Alto CDMO boosts induced pluripotent stem cell manufacturing capacity
I Peace, Inc, which was founded in 2015 and is headquartered in Palo Alto, said the work is nearing completion, with it expecting to start manufacturing cGMP grade cells in April this year, allowing it to meet the growing needs for GMP iPSC lines from pharma companies and cell therapy developers.
The biotech has developed a technology that it says simplifies the process of generating iPSCs while also automating the preparation process using advanced robotics and fluidics technology.
Its said its proprietary manufacturing platform enables the fully-automated mass production of discrete iPSCs from multiple donors in a single room. "Increasing the available number of clinical-grade iPSC lines allows our customers to take differentiation propensity into account and select the most appropriate iPSC line for their own clinical research, all at significantly reduced cost."
I Peace said the facility is listed on the US FDA drug establishments current registration site, while details of its clinical-grade iPSC manufacturing process are registered in the FDA Drug Master File (DMF). “The facility registration, along with DMF registration and GMP certification provide peace of mind to clients looking to use our iPSCs for clinical and commercial use.”
The manufacturing site was also awarded a permit in 2020 by Japan’s health ministry to manufacture specific cell-based products.
Promise of iPSC technology
While comparatively new in the cell therapy space, iPSC technology has garnered considerable interest due to the potential it holds for cell therapy development.
Other companies active in the iPSC space include Treefrog Therapeutics, Catalent, through its recent acquisition of RheinCell Therapeutics, and Ncardia.