Degradation of biotherapeutics during manufacturing processes and its solution
文献类型：期刊论文
| 作者 | Fang Weijie2; Huang Yongzhuo1 ; Fai Poon H4; Hu Xingjiang3
|
| 刊名 | Journal of International Pharmaceutical Research
 |
| 出版日期 | 2017 |
| 卷号 | 44期号:11页码:1012-1018 |
| 关键词 | biotherapeutics stability manufacturing process degradation mechanism |
| ISSN号 | 1674-0440 |
| 其他题名 | 生物药在生产过程中的稳定性问题及解决方案 |
| 文献子类 | Review |
| 英文摘要 | Recently,biotherapeutics,especially monoclonal antibody- based biotherapeutics,have become increasingly important as novel therapeutic products. However,biotherapeutics are usually not only complex in structure,but also unstable,especially during the manufacturing bioprocesses,leading to their degradation and inactivation. The manufacturing prccesses are substantially complex,and generally include drug substance biosynthesis(i.e. fermentation or cell culture),purification and refinement(i.e. chromatography and viral clearance),and drug product formulation and fill-finish(i.e. compounding,sterilization,filling,freeze-drying and inspection). Therefore,it is of vital importance for biotherapeutics to remain stable during manufacturing processes. This review summarizes major factors that affect the degradation of biotherapeutics during manufacturing processes and proposes corresponding solutions in each step of the manufacturing process. |
| 资助项目 | 国家重大新药创制科技重大专项资助项目[00000000] ; 国家自然科学基金资助项目[00000000] |
| WOS研究方向 | Pharmacology & Pharmacy (provided by Clarivate Analytics) |
| 语种 | 中文 |
| CSCD记录号 | CSCD:6202540 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/269186]  |
| 专题 | 药物制剂研究中心 |
| 作者单位 | 1.Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.; 2.College of Pharmaceutical Sciences,Zhejiang University, Hangzhou, Zhejiang 310058, China.; 3.Research Center for Clinical Pharmacy,The First Affiliated Hospital,Zhejiang University, Hangzhou, Zhejiang 310003, China. 4.QuaCell Biotechnology Ltd., Zhongshan, Guangdong 528437, China.; |
| 推荐引用方式 GB/T 7714 | Fang Weijie,Huang Yongzhuo,Fai Poon H,et al. Degradation of biotherapeutics during manufacturing processes and its solution[J]. Journal of International Pharmaceutical Research,2017,44(11):1012-1018. |
| APA | Fang Weijie,Huang Yongzhuo,Fai Poon H,&Hu Xingjiang.(2017).Degradation of biotherapeutics during manufacturing processes and its solution.Journal of International Pharmaceutical Research,44(11),1012-1018. |
| MLA | Fang Weijie,et al."Degradation of biotherapeutics during manufacturing processes and its solution".Journal of International Pharmaceutical Research 44.11(2017):1012-1018. |
入库方式： OAI收割
来源：上海药物研究所
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