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Manufacturing of Pharmaceutical Proteins : From Technology to Economy.
Structured 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....
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken :
Wiley,
2015.
|
| Edición: | 2nd ed. |
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
| LEADER | 00000cam a2200000Mi 4500 | ||
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| 037 | |a 9783527683086 |b Wiley | ||
| 050 | 4 | |a HD9665.5 ǂb B446 2015eb | |
| 082 | 0 | 4 | |a 615.19 |
| 049 | |a UAMI | ||
| 100 | 1 | |a Behme, Stefan. | |
| 245 | 1 | 0 | |a Manufacturing of Pharmaceutical Proteins : |b From Technology to Economy. |
| 250 | |a 2nd ed. | ||
| 260 | |a Hoboken : |b Wiley, |c 2015. | ||
| 300 | |a 1 online resource (458 pages) | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 588 | 0 | |a Print version record. | |
| 505 | 0 | |a 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 Microorganisms. | |
| 505 | 8 | |a 1.3.1.1 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. | |
| 505 | 8 | |a 2.3.2 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. | |
| 505 | 8 | |a 2.4.3.2 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. | |
| 505 | 8 | |a 2.5.4 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. | |
| 500 | |a 3.2.8.5 Electrophoresis. | ||
| 520 | |a Structured 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. | ||
| 504 | |a Includes bibliographical references and index. | ||
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Pharmaceutical industry. | |
| 650 | 0 | |a Protein drugs. | |
| 650 | 2 | |a Drug Industry | |
| 650 | 6 | |a Industrie pharmaceutique. | |
| 650 | 6 | |a Médicaments protéiques. | |
| 650 | 7 | |a Pharmaceutical industry |2 fast | |
| 650 | 7 | |a Protein drugs |2 fast | |
| 758 | |i has work: |a Manufacturing of pharmaceutical proteins (Text) |1 https://id.oclc.org/worldcat/entity/E39PCG7rwVhyvdGm3cDRRjFKYd |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Print version: |a Behme, Stefan. |t Manufacturing of Pharmaceutical Proteins : From Technology to Economy. |d Hoboken : Wiley, ©2015 |z 9783527337668 |
| 856 | 4 | 0 | |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=1896075 |z Texto completo |
| 938 | |a EBL - Ebook Library |b EBLB |n EBL1896075 | ||
| 994 | |a 92 |b IZTAP | ||