Manufacturing of pharmaceutical proteins : from technology to economy / Stefan Behme.

Format:

Book

Author/Creator:

Behme, Stefan, author.

Language:

English

Subjects (All):

Pharmaceutical industry.

Protein drugs.

Physical Description:

1 online resource (458 p.)

Edition:

Second, revised and expanded edition.

Place of Publication:

Weinheim, Germany : Wiley-VCH, 2015.

Language Note:

English

Summary:

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.

Contents:

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

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

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

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

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

3.2.8.5 Electrophoresis

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on online resource; title from PDF title page (ebrary, viewed March 4, 2015).

ISBN:

9783527683086

3527683089

9783527683109

3527683100

9783527683093

3527683097

OCLC:

904405253