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Mingyang Gu

Time: 2024-09-07 Author: admin_develop Browse: 7

Graduated from Xuzhou Medical University, licensed pharmacist, engineer, joined Suzhou Otsuka Pharmaceutical Co., LTD., after graduation in 2007, during the period of 2 years of technical study in the Japanese headquarters, to assist the Chinese drug regulatory department of grass powder liquid double compartment bag technical standards. Successfully introduced Japan's global powder liquid double-compartment bag products into China through technology transfer and commercialized sales, and successfully exported China's large-capacity aseptic preparation products to Japan and overseas for the first time, and participated in the translation and writing of the 2010 edition of GMP Aseptic Drugs. After joining Wuxi Junol, I was responsible for the quality management and verification of two bases in Shanghai and Suzhou. In 2021, China's first self-developed Class 1 biologics CAR-T cell therapy product was approved for market, led the preparation of the first lentiviral vector production line of Wuxi Junol, and was responsible for the confirmation and verification of plant facilities and equipment. Participated in the two-in-one verification of biological products, capacity expansion, GMP and registration verification of new cell therapy production lines for many times. In 2023, he joined Envision Immune, responsible for the establishment of quality system and assisting in the development of R&D projects. As a quality expert, he has been invited to give keynote speeches at domestic forums (Suzhou Etrade Conference, Biological drug Quality Science Conference, biological drug Development Conference, International Cell and Gene Therapy Conference, etc.) for many times.