LEADER 05327nam 2200661 450 001 9910828171603321 005 20230807213624.0 010 $a3-527-68308-9 010 $a3-527-68310-0 010 $a3-527-68309-7 035 $a(CKB)3710000000357847 035 $a(EBL)1896075 035 $a(SSID)ssj0001471095 035 $a(PQKBManifestationID)11917799 035 $a(PQKBTitleCode)TC0001471095 035 $a(PQKBWorkID)11423323 035 $a(PQKB)11489669 035 $a(MiAaPQ)EBC1896075 035 $a(MiAaPQ)EBC4044593 035 $a(Au-PeEL)EBL1896075 035 $a(CaPaEBR)ebr11022764 035 $a(CaONFJC)MIL769809 035 $a(OCoLC)904405253 035 $a(EXLCZ)993710000000357847 100 $a20150304h20152015 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aManufacturing of pharmaceutical proteins $efrom technology to economy /$fStefan Behme 205 $aSecond, revised and expanded edition. 210 1$aWeinheim, Germany :$cWiley-VCH,$d2015. 210 4$dİ2015 215 $a1 online resource (458 p.) 300 $aDescription based upon print version of record. 311 $a3-527-33766-0 320 $aIncludes bibliographical references and index. 327 $aCover; Contents; Preface; Preface to First Edition; List of Abbreviations; Part I: Introduction; Chapter 1 Biopharmaceutical Production: Value Creation, Product Types, and Biological Basics Introduction; 1.1 Role of Production in Pharmaceutical Biotechnology; 1.1.1 Relationship Between Production and Development; 1.1.2 Relationship Between Production and Marketing; 1.2 Product Groups; 1.2.1 Vaccines; 1.2.2 Pharmaceuticals from Blood and Organs; 1.2.3 Recombinant Therapeutic Proteins; 1.2.4 Cell and Gene Therapeutics; 1.2.5 Antibiotics; 1.3 Basics of Biology; 1.3.1 Cells and Microorganisms 327 $a1.3.1.1 Structure and Types of Cells1.3.1.2 Metabolism; 1.3.1.3 Reproduction and Aging; 1.3.1.4 Viruses and Bacteriophages; 1.3.1.5 Protein Biosynthesis; 1.3.2 The Four Molecular Building Blocks of Biochemistry; 1.3.2.1 Proteins; 1.3.2.2 Nucleic Acids; 1.3.2.3 Polysaccharides; 1.3.2.4 Lipids; Part II: Technology; Chapter 2 Manufacturing Process; 2.1 Role of the Manufacturing Process in Biotechnology; 2.2 Process Schematic and Evaluation; 2.2.1 Drug Substance Manufacturing; 2.2.2 Drug Product Manufacturing; 2.2.3 Key Factors for Process Evaluation; 2.3 Cell Bank; 2.3.1 Expression Systems 327 $a2.3.2 Microbial Systems2.3.2.1 Mammalian Systems; 2.3.2.2 Transgenic Systems; 2.3.3 Manufacturing and Storage of the Cell Bank; 2.4 Fermentation; 2.4.1 Basic Principles; 2.4.1.1 Cell Growth and Product Expression; 2.4.1.2 Comparison of Batch and Continuous Processes; 2.4.1.3 Sterility and Sterile Technology; 2.4.1.4 Comparison of Fermentation with Mammalian Cells and Microorganisms; 2.4.2 Technologies and Equipment; 2.4.2.1 Fermentation in Suspension Culture; 2.4.2.2 Adherent Cell Cultures; 2.4.2.3 Transgenic Systems; 2.4.3 Raw Materials and Processing Aids; 2.4.3.1 Nutrient Media 327 $a2.4.3.2 Water, Gases, and Other Processing Aids2.4.4 Overview of Fermentation; 2.5 Purification; 2.5.1 Basic Principles; 2.5.1.1 Basic Pattern of Purification; 2.5.1.2 Types of Impurities; 2.5.1.3 Principles of Separation Technologies; 2.5.2 Technologies for Cell Separation and Product Isolation; 2.5.2.1 Cell Separation; 2.5.2.2 Cell Disruption, Solubilization, and Refolding; 2.5.2.3 Concentration and Stabilization; 2.5.3 Technologies for Final Purification; 2.5.3.1 Chromatographic Processes; 2.5.3.2 Precipitation and Extraction; 2.5.3.3 Sterile Filtration and Virus Removal 327 $a2.5.4 Raw Materials and Processing Aids2.5.4.1 Gels for Chromatography; 2.5.4.2 Membranes for TFF; 2.5.5 Overview of Purification; 2.6 Formulation and Filling; 2.6.1 Basic Principles; 2.6.2 Freeze-Drying; 2.7 Labeling and Packaging; Chapter 3 Analytics; 3.1 Role of Analytics in Biotechnology; 3.2 Product Analytics; 3.2.1 Identity; 3.2.2 Content; 3.2.3 Purity; 3.2.4 Activity; 3.2.5 Appearance; 3.2.6 Stability; 3.2.7 Quality Criteria of Analytical Methods; 3.2.8 Analytical Methods; 3.2.8.1 Amino Acid Analysis; 3.2.8.2 Protein Sequencing; 3.2.8.3 Peptide Mapping; 3.2.8.4 Protein Content 327 $a3.2.8.5 Electrophoresis 330 $aStructured like a textbook, the second edition of this referencecovers all aspects of biopharmaceutical manufacturing, includinglegal and regulatory issues, production facility design, andquality assurance, with a focus on supply chain management andregulations in emerging markets and cost control.
The author has longstanding industrial expertise inbiopharmaceutical production and years of experience teaching atuniversities. As such, this practical book is ideal for use inacademia as well as for internal training within companies. 606 $aPharmaceutical industry 606 $aProtein drugs 615 0$aPharmaceutical industry. 615 0$aProtein drugs. 676 $a615.19 700 $aBehme$b Stefan$01606456 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910828171603321 996 $aManufacturing of pharmaceutical proteins$93932256 997 $aUNINA