PALO ALTO, Calif., Dec. 4, 2020 /PRNewswire/ — I Peace, Inc., a Palo Alto-based biotech start-up focusing on Nobel Prize-winning induced pluripotent stem cell (iPSC) technology obtains approval from an independent Institutional Review Board (IRB) for the process of generating iPSCs—including donor recruiting, screening, blood draw, iPSC generation, storage, and distribution—for commercial use.
The IRB which reviewed I Peace’s process is an Association for the Accreditation of Human Research Protection Programs (AAHRPP) and ISO 9001:2015 accredited IRB that is routinely inspected by the US Food and Drug Administration (FDA) and found to be in good standing and compliant with federal regulations. In accordance with FDA regulations, an IRB is a group that has the authority to approve, require modifications (to secure approval), or disapprove study protocols, informed consent forms, and other related documents. This group review serves an important role in the protection of the rights and welfare of human research subjects, according to the FDA.
Implications of obtaining IRB approval
IRB review acknowledged that I Peace’s iPSC production process for commercial use and all documents involved in the process, including the content of informed consent and medical history questionnaire, personal information handling protocols, and cell production and storage procedures, meet the FDA’s ethical standards.
This allows research institutions and companies to use our iPSCs for clinical research with confidence. In addition, I Peace has been certified and granted the use of PrivacyMark® by JIPDEC, as an institution with a system established to take appropriate protective measures for personal information. These approvals and certifications allow donors and clients to take part in our iPSC production service with confidence from both a personal information protection perspective and an ethical perspective.
About I Peace, Inc
I Peace, Inc. is a global supplier of clinical and research grade iPSCs. It was founded in 2015 at Palo Alto, California, USA by Dr. Tanabe, who earned his doctorate at Kyoto University under Nobel laureate Dr. Yamanaka. I Peace’s mission is to alleviate the suffering of diseased patients and help healthy people maintain a high quality of life by making cell therapy accessible to all. I Peace’s state-of-the-art GMP facility and 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 to select the most appropriate iPSC line for their clinical research at significantly reduced cost. Our goal is to create iPSCs for every individual that become his/her stem cell for life.
Founder, CEO：Koji Tanabe
Head Quarter: Palo Alto, California
Japan subsidiary: I Peace, Ltd. (Kyoto, Japan)
Cell Manufacturing Facility: Kyoto, Japan