I Peace has invested over $10 million to expand its Palo Alto, California plant, tripling capacity to manufacture iPS and iPSC-derived differentiated cells.
I Peace, a contract development manufacturing organization (CDMO) start-up, has tripled its capacity to produce induced pluripotent stem (iPS) cells and induced pluripotent stem cells (iPSC) by expanding its facility.
The firm claims that the plant expansion will meet the demand for iPS cells from pharmaceutical companies and cell therapy manufacturers, as well as providing individuals with personal iPS cell banking service capacity.
“Equipment including incubators, isolators, a monitoring system, and other equipment are integrated for CDMO services to manufacture GMP-iPSC and iPSC-derived cell products to provide them to pharmaceutical companies and research institution all over the world,” a spokesperson for I Peace told us.
“In addition, it also includes our proprietary in-house mass production system to meet growing demand for personalized iPSC banking service. We are building and expanding the automated facility to manufacture GMP cell products.”
The expansion is close to completion and the CDMO anticipates beginning manufacturing cells in April this year after finishing a regulatory review and Food and Drug Administration (FDA) registration update.
Furthermore, the facility is listed on the FDA “Drug Establishments Current Registration Site,” and is certified as cGMP compliant. This registration establishes I Peace’s cell manufacturing plant as suitable for drug production, based on information submitted to the organization.
The spokesperson said the number of companies and organizations developing iPSC-derived cell therapies has “exploded in the past few years and are expected to grow exponentially in the coming years.”
“iPSCs can be differentiated to any somatic cell type and recent advances in differentiation and culturing technologies has enabled further cell therapy development. Several first-in-human clinical trials have been performed all over the world with high safety and efficacy. This has led to increased demand for personal iPSC banking service as well.”
The CDMO will hire ten employees, which includes manufacturing, regulatory quality assurance, and quality control staff.