Biological drug analysis and testing

Author: Yang Rude
Publisher:
Publish Date: 2002-02-28
Features: This book discusses the fundamental principles of quality analysis and testing of biologic drugs, as well as commonly used modern analytical and testing methods for biologic drugs. The main content includes an introduction, enzyme analysis, immunoassay analysis, high-performance liquid chromatography and its applications, bioassay, impurity and safety testing, testing of amino acids, peptides, proteins, and enzyme drugs, testing of carbohydrate, lipid, and nucleic acid drugs, etc. In addition, it also adds quality control of gene-engineered drugs and testing methods for 14 gene-engineered drugs (including recombinant human insulin, growth hormone, interferon, interleukin, erythropoietin, colony-stimulating factor, tissue-type plasminogen activator, tumor necrosis factor, etc.). This book can serve as a teaching material for undergraduate and junior college students majoring in biotechnology, pharmaceutical engineering, and related pharmacy disciplines, and can also be used as a reference book for graduate students and personnel engaged in the production, research, and analysis of biologic drugs.