05326nam 2200661 450 991078734540332120230807213624.03-527-68308-93-527-68310-03-527-68309-7(CKB)3710000000357847(EBL)1896075(SSID)ssj0001471095(PQKBManifestationID)11917799(PQKBTitleCode)TC0001471095(PQKBWorkID)11423323(PQKB)11489669(MiAaPQ)EBC1896075(MiAaPQ)EBC4044593(Au-PeEL)EBL1896075(CaPaEBR)ebr11022764(CaONFJC)MIL769809(OCoLC)904405253(EXLCZ)99371000000035784720150304h20152015 uy 0engur|n|---|||||txtccrManufacturing of pharmaceutical proteins from technology to economy /Stefan BehmeSecond, revised and expanded edition.Weinheim, Germany :Wiley-VCH,2015.©20151 online resource (458 p.)Description based upon print version of record.3-527-33766-0 Includes bibliographical references and index.Cover; 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 Microorganisms1.3.1.1 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 Systems2.3.2 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 Media2.4.3.2 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 Removal2.5.4 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 Content3.2.8.5 ElectrophoresisStructured 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. <br />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.Pharmaceutical industryProtein drugsPharmaceutical industry.Protein drugs.615.19Behme Stefan991657MiAaPQMiAaPQMiAaPQBOOK9910787345403321Manufacturing of pharmaceutical proteins2269571UNINA01749nam2 2200313 i 450 CFI016573220251003044127.08802045259IT91-3980 20061031d1991 ||||0itac50 baitaitz01i xxxe z01nz01ncRDAcarrierˆ22: ‰Appendice di aggiornamento\a cura di Paolo Mengozzi et al.!TorinoUTET©1991XXXII, 809 p.25 cm.001CFI00123772001 Trattato di diritto privatodiretto da Pietro Rescigno22346.00221346.45DIRITTO PRIVATO. ITALIA21Mengozzi, PaoloCFIV008259ITIT-00000020061031IT-BN0095 IT-SA0112 IT-CE0068 CFI0165732Biblioteca Centralizzata di Ateneov. 1- 3.2(3. copia),4.3 (2. copia), 5.1 (3.copia); 6.2-8.2 (2. copia),9.1-11.3 (3. copia),12.4-13.5 (2. copia),14.6 (3. copia), 15.1-15.2 (2. copia);16.2 (2. copia); 16.4;17.3 (3. copia)-19.1 (2. copia)-20.1 (3. copia)-21-22 (2. copia) 01TRA 2 TRADDP 01AR 0000093865 VMA (0022 v. 22B 2025021120250211v. 1- 3.2(3. copia),4.3 (2. copia), 5.1 (3.copia); 6.2-8.2 (2. copia),9.1-11.3 (3. copia),12.4-13.5 (2. copia),14.6 (3. copia), 15.1-15.2 (2. copia);16.2 (2. copia); 16.4;17.3 (3. copia)-19.1 (2. copia)-20.1 (3. copia)-21-22 (2. copia) 01TRA 2 TRADDP 01S 0090017525 VMA (0022 bis v. 22 (2. copia)B 2025021120250211 01 84 CPAppendice di aggiornamento895079UNISANNIO