From the perspective of CMC, how to speed up the BLA declaration of biologics
From the perspective of CMC, how to speed up the BLA declaration of biologics
随着疫情的常态化,更多项目数据将支持监管机构进行科学评估,以进一步催生生物工艺开发的变革,生物药的研发周期也有望进一步压缩。本白皮书将简要从 CMC 角度阐述如何加速生物制剂 BLA 的申报策略。

Added Date:

2023-02-19

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