PersonGen-Anke Cellular Therapeutics Co., Ltd. was established on November 17, 2016 in Hefei High-Tech Zone, Anhui Province, China. PersonGen-Anke, as the manufacturing plant of PersonGen, offers more than 2000 square meters of floor space for the whole GMP production line of CAR-T cell therapeutics, including production of purified DNA plasmid, production of clinical-grade lentivirus, and the clinical-scale CAR-T cell processing and manufacturing. The GMP manufacturing facility also contains a P2 (BSL-2) laboratory and quality control laboratories equipped with advanced instruments and devices. In every step of CAR-T manufacturing, the most comprehensive quality tests are conducted to ensure the patient safety and therapeutic efficacy of the products.
Currently, PersonGen-Anke has an advanced CAR T cell processing and manufacturing platform in the world. The platform is a fully-automated, single-used and functionally-closed system which allows robust and scalable GMP production of CAR-T cells as well as other cell types. In Dec. 2019, PersonGen-Anke received the official IND approval from National Medical Products Administration of China for its CD19 autologous CAR-T cell infusion (application number: CXSL1700216). The product is the first, and so far the only, IND-approved CAR-T therapy based on a completely automated manufacturing process in China.
Since the inception of PersonGen-Anke, the company has been committed to being the most advanced translational research center in China for the development of innovative cellular immunotherapies. The company received research funding from "Anhui Province Strategic Emerging Industrial Cluster Development Base" in 2017. The efforts of the company was also recognized by several awards including: Anhui Province Emerging Strategic Industry Technology Leader Prize, the second prize of China Innovation and Entrepreneurship Competition, the first place of “Creative China” in Anhui region, the Luzhou Industry Innovation Team, Hefei Entrepreneurship Leadership Talent, and Key Research and Development Plan in Anhui Province, etc.
By leveraging the world-class platforms of PersonGen, the clinical-quality CAR-T cell products manufactured by PersonGen-Anke have shown excellent safety and efficacy in the clinical trials. So far, the company has already developed the GMP manufacturing processes for several first-in-class CAR-T cell products. PersonGen-Anke currently plays a key role in the global deployment of PersonGen by providing the technical and scientific support for IND applications and clinical trials in different countries.