為大家推薦生物藥CMC長期學習的15本書籍，書單如下：

領取方式：1、找注冊圈管理員領取；2、也可以在抗體君后臺留言CMC領取。

01 藥物發(fā)現(xiàn)?

書名：Antibody Drug Discovery

02 分子生物?

書名：Lewin’s GENES XII

03 細胞株開發(fā)

書名：Cell Line Development

04 上游工藝

書名：Cell Culture Bioprocess Engineering

05 下游工藝

書名：Downstream Industrial Biotechnology Recovery and Purification

06 灌裝工藝

書名：Sterile drug products formulation, packaging, manufacturing, and?quality

07 分析方法

書名：Biophysical characterization of proteins in developing biopharmaceuticals

08 GMP生產(chǎn)

書名：Good Manufacturing Practices for Pharmaceuticals

09 工藝表征

書名：A-Mab case study

10 工藝驗證

書名：Process Validation in Manufacturing Biopharmaceuticals Guidelines

11 技術轉移

書名：Technology Transfe Guideline

12 CMC管理

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

13 QbD理念

書名：Quality by Design for Biopharmaceutical Drug Product Development

14 藥物申報

書名：Drugs From Discovery to Approval

15 ICH指南?

書名：ICH Quality Guidelines An Implementation Guide