我和平

2022年11月1日

分享本文分享本文加利福尼亞州帕洛阿爾托，2022年11月1日/PRNewswire/—I Peace, Inc. (https://www.ipeace.com)宣布公司已同意加入加州再生醫學研究所(CIRM)的行業資源夥伴計劃，為CIRM資助的各種研究項目提供良好生產規範(GMP) iPSCs鋪平道路。在過去的幾年裏，I Peace一直為各種細胞治療開發商和製藥公司提供GMP誘導多能幹細胞(iPSC)，我們相信與CIRM的良好合作關係反映了我們細胞產品和配套服務的高質量。通過I Peace的專有技術和深厚的iPSC專業知識，I Peace為再生醫學產品開發提供從GMP iPSC衍生的研究級iPSC。CIRM獲獎者還將獲得CIRM轉化和臨床階段項目的I Peace GMP製造服務。在加州55億美元的資助下，CIRM已經資助了82個臨床試驗，並支持了超過152個活躍的再生醫學研究項目，從候選發現到III期臨床試驗。I和平細胞生產設施通過了cGMP認證，並在FDA“藥品機構當前注冊網站”上列出。根據提交給FDA的詳細信息，注冊確認I Peace的細胞生產設施適合於藥物生產。臨床級iPSC生產的全麵細節在FDA藥品主文件(DMF)中注冊。工廠注冊、DMF注冊和GMP認證為希望在美國、日本和其他全球市場將我們的iPSCs用於臨床和商業用途的客戶提供了安心。I Peace在FDA藥品機構當前注冊網站上的列表幫助我們的客戶通過引用FDA機構標識符(FEI)獲得FDA批準的信息。 The current facility was certified by a third party as GMP compliant, and the current GMP certification pertains to: ICH-Q7, a global guideline for the manufacturing of active pharmaceutical ingredients; 21 CFR 210/211, US regulations for manufacturing, processing, packing, or holding of drugs, and for finished pharmaceuticals and; 21 CFR 1271, US regulations for human cell and tissue products. The facility was also awarded a permit in 2020 by Japan's Ministry of Health, Labour, and Welfare to manufacture specific cell-based products. I Peace, inc. I Peace, inc. offers global GMP iPSC manufacturing and CDMO services. The company was founded in 2015 by Koji Tanabe, a graduate of Professor Shinya Yamanaka's laboratory at Kyoto University and the second author of the paper that reported the successful establishment of the world's first human iPS cell line. Tanabe has been involved in iPS cell research since the early days of its development and is constantly working on innovative technical development to make iPS cells accessible to everyone through I Peace, Inc. Our unique technologies allow us to produce multiple donor-derived iPS cells in parallel and enable us to minimize contamination concerns and to provide a large number of iPS cells at competitive prices. Our global cGMP facility is fully compliant with 21 CFR 210/211 and ICH Q7 FDA(US) and PMDA (Japan) registered and listed EudraLex compliant. Our cell products have been trusted by numerous pharmaceutical companies and cell therapeutics development companies. We also provide personal iPSC banking services for individuals. Our core belief is that everyone in the world will have the access to their own iPS cells for their cell therapies. I Peace, Inc.