近年来,细胞治疗产品,尤其是嵌合抗原受体T细胞(CAR-T)的研发与临床应用发展迅猛。在美国临床试验网站检索全球CAR-T细胞治疗临床试验登记数可以发现,中国所登记的项目数仅次于美国,居全球第二。迄今为止,国内已有近二十家公司拿到了CAR-T细胞疗法的临床批件[1]。
疾控中心的建设要符合我国现行的生物安全实验室各项标准,目前国际上依据实验室所处理对象的生物危险程度,把生物安全实验室分为四级:一级对生物安全隔离的要求最低,四级最高。我国目前有两个四级生物安全实验室:湖北武汉BSL-4病毒实验室(中国科学院武汉国家生物安全实验室 )和国家动物疫病防控高级别生物安全实验室(中国农业科学院哈尔滨兽医研究所)。
Digitising process development can reduce the time delay between sampling and availability, and can increase the quality of the data obtained
Process control is a central task in bioprocess development and production. Apart from common control tasks including pH, temperature or dissolved oxygen, more advanced control tasks must be mastered. Real-time availability of analytical data is ofte
To facilitate optimal process control limiting substrates must be identified, moni-tored and controlled. Amino acids are often critical substances, especially in mam-malian processes. Measurement and thus monitoring is tedious and rarely done.