生物药CMC学习的15本书籍

为大家推荐生物药CMC长期学习的15本书籍，书单如下：

领取方式：1、找注册圈管理员领取；2、也可以在抗体君后台留言CMC领取。

01 药物发现 

书名：Antibody Drug Discovery

02 分子生物 

书名：Lewin’s GENES XII

03 细胞株开发

书名：Cell Line Development

04 上游工艺

书名：Cell Culture Bioprocess Engineering

05 下游工艺

书名：Downstream Industrial Biotechnology Recovery and Purification

06 灌装工艺

书名：Sterile drug products formulation, packaging, manufacturing, and quality

07 分析方法

书名：Biophysical characterization of proteins in developing biopharmaceuticals

08 GMP生产

书名：Good Manufacturing Practices for Pharmaceuticals

09 工艺表征

书名：A-Mab case study

10 工艺验证

书名：Process Validation in Manufacturing Biopharmaceuticals Guidelines

11 技术转移

书名：Technology Transfe Guideline

12 CMC管理

书名：Biopharmaceutical Processing Development, Design, and Implementation of Manufacturing Processes

13 QbD理念

书名：Quality by Design for Biopharmaceutical Drug Product Development

14 药物申报

书名：Drugs From Discovery to Approval

15 ICH指南 

书名：ICH Quality Guidelines An Implementation Guide