该基地提供从临床前到商业化生产的原料药工艺开发和生产。基地设有5个车间,包括用于生产高活原料药、酶发酵和流动化学的车间。总反应釜体积近400立方米。
它支持各种原料药赋能技术,例如结晶和颗粒工程、生物催化、连续生产(流动化学)、化学催化,以及制备级HPLC、SFC和SMB。
我们的金山基地已成功通过美国FDA、欧洲药品管理局、中国NMPA、日本PMDA、韩国MFDS和巴西ANVISA的多次检查。
该基地提供从临床前到商业化生产的原料药工艺开发和生产。基地设有5个车间,包括用于生产高活原料药、酶发酵和流动化学的车间。总反应釜体积近400立方米。
它支持各种原料药赋能技术,例如结晶和颗粒工程、生物催化、连续生产(流动化学)、化学催化,以及制备级HPLC、SFC和SMB。
我们的金山基地已成功通过美国FDA、欧洲药品管理局、中国NMPA、日本PMDA、韩国MFDS和巴西ANVISA的多次检查。
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