新闻和视图
Beigene选择GE Healthcare的现成的生物制厂,以提高其癌症药物的制造能力
2018年9月18日
Beigene,Ltd选择了GE Healthcare Life Sciences的现成生物制造设施,Kubio用于大规模生产其癌症单克隆抗体(MABS)。
库比奥将位于中国广东省广州广州,那里越来越多的生物技术公司正在建立运营。该设施的第一阶段预计将在2019年完成并运营。Beigene已经在其现有的中国苏州现有制造工厂中的GE Healthcare的FlexFactory使用GE Healthcare的FlexFactory来制造MABS进行临床试验。
“为了实现我们开发创新的解决方案来帮助中国和全球癌症患者的使命,贝吉恩不仅在研发中,而且在制造业中都专注于质量和敏捷性。我们认为,实施Kubio设施将帮助我们生产具有高质量标准的抗体药物,以满足癌症患者的未满足和紧急需求。贝吉的生物学。
“ Beigene是中国领先的生物技术公司之一,致力于为全球新的癌症疗法的患者提供服务。我们认为,库比奥将使用符合最高监管标准的灵活和可靠的制造平台,帮助贝吉尼更快地到达中国和全球市场。
GE Healthcare’s KUBio can be constructed, assembled and fully fitted-out to current Good Manufacturing Practices (cGMP) standards in approximately 18 months, which is up to 50% faster than traditional manufacturing facilities that usually require approximately three years before they are fully commissioned and qualified. The facility is based on the single-use technologies that bring flexibility and are designed to yield higher productivity by increasing the number of lots manufactured, reducing maintenance requirements and shortening downtime between batches and products. GE Healthcare Life Sciences has delivered three KUBios to China and over 50 FlexFactories globally.