The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
CMC 监管合规性对生物制药的挑战 第3版
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作 者
出版时间
2019年06月14日
装 帧
精装
页 码
426
语 种
英文
版 次
3rd Ed.
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图书简介
Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing
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