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In this new edition of the only resource to systematically cover all post-production issues, over 70% of the content is new or rewritten in line with the rapidly evolving technology in the field. By combining the experience of academic experts, managers from the pharmaceutical and biotech industry, as well as independent consultants, biological product recovery is viewed from every possible angle, including biosafety and regulatory issues.
List of Contributors.
Part I Strategy and Development.
1 Process Development – When to Start, Where to Stop (Glenwyn D. Kemp).
1.1 Introduction – What is Process Development?
1.2 The Challenges of Process Development.
1.3 Strategies to Develop a Downstream Process.
1.4 Process Optimization.
1.5 Future Trends in Process Development.
2 Strategies in Downstream Processing (Yusuf Chisti).
2.2 Overview of Process Considerations.
2.3 Product Quality and Purity Specifications.
2.4 Impact of Fermentation on Recovery.
2.5 Initial Separations and Concentration.
2.6 Intracellular Products.
2.7 Some Specific Bioseparations.
2.8 Recombinant and Other Proteins.
2.8.1 Inclusion Body Proteins.
Part II Bioprocess and Early DSP.
3 Processes Development and Optimization for Biotechnology Production – Monoclonal Antibodies (Jochen Strube, Sven Sommerfeld, and Martin Lohrmann).
3.2 Monoclonal Antibody Production.
3.3 Process Development and Optimization.
3.4 Production Processes.
3.5 Process Analysis: Optimization Potential.
4 Dynamics of Cellular Response to Recombinant Protein Overexpression in Escherichia coli (Balaji Balagurunathan and Guhan Jayaraman).
4.2 Global Analysis of the Cellular Response to Recombinant Protein Overexpression.
4.3 Metabolic Consequences of Recombinant Protein Overexpression.
4.4 Strategies to Overcome the Metabolic Consequences of Recombinant Protein Overexpression.
4.5 Consequences of Recombinant Protein Overexpression on the Protein Maintenance Machinery in the Cell.
4.6 Strategies to Overcome Cellular Stress Response Induced due to Recombinant Protein Overexpression.
4.7 Concluding Remarks.
Part III Preparative (Chromatographic) Methods.
5 Ion-exchange Chromatography in Biopharmaceutical Manufacturing (Lothar Jacob and Christian Frech).
5.2 Ion-exchange Chromatography in the Downstream Processing of Proteins.
5.3 Development and Optimization Strategies.
5.4 Scale-up of Ion-exchange Chromatography.
5.5 Application Areas.
6 Displacement Chromatography of Biomacromolecules (Ruth Freitag).
6.2 Background and Basic Principle of Displacement Chromatography.
6.3 Modeling and Simulation of Displacement Chromatography.
6.4 Technical Aspects and Process Development.
6.5 Displacers for Biopolymer Displacement Chromatography.
6.6 Special Variants of Displacement Chromatography.
6.7 Applications of Displacement Chromatography for Separations in Biotechnology.
7 The Purifi cation of Biomolecules by Countercurrent Chromatography (Ian J.Garrard).
7.1 A Description of Countercurrent Chromatography.
7.2 Countercurrent Chromatography Compared to Solid-phase Chromatography.
7.3 Solvent System Selection Process.
7.4 Countercurrent Chromatography of Polar Biomolecules.
7.5 Aqueous Polymer Systems.
8 Continuous Chromatography in the Downstream Processing of Products of Biotechnological and Natural Origin (Michael Schulte, Klaus Wekenborg, and Jochen Strube).
8.2 SMB Chromatography.
8.3 Continuous Annular Chromatography.
8.5 Conclusions and Outlook.
9 Continuous Annular Chromatography (Frank Hilbrig and Ruth Freitag).
9.2 Continuous Annular Chromatography – The Basic Principle.
9.3 Development of Instrumentation and Operation.
9.4 Modern Continuous Annular Chromatography Systems.
9.5 Theory and Modeling of Continuous Annular Chromatography.
9.6 Issues of Continuous Annular Chromatography Application in Bioseparation and Bioprocessing.
9.7 Applications of Continuous Annular Chromatography Separation in Biotechnology.
9.8 Continuous Reactor/Separators.
10 Principles of Membrane Separation Processes (Yusuf Chisti).
10.2 Membrane Separation Processes.
10.3 Membrane Characteristics.
10.4 Filtration Basics.
10.5 Membrane Modules.
10.6 Operation of Membrane Filtration Systems.
10.7 Membrane Fouling and Cleaning.
10.8 Economics of Membrane Processes.
11 Affinity Precipitation (Frank Hilbrig and Ruth Freitag).
11.2 Primary-effect Af. nity Precipitation.
11.3 Affinity Precipitation by Stimuli-responsive Materials.
11.4 Application of Af. nity Precipitation in Bioseparation.
Part IV Specifi c Bioprocesses and Separation Methods.
12 Biological Fuel Cells: Processing Substrates to Electricity by the Aid of Biocatalysts (Aarne Halme and Xia-Chang Zhang).
12.2 Microbial Fuel Cells.
12.3 Enzymatic Fuel Cells.
12.4 Summary and Conclusion.
13 Removal and Analysis of Contaminants and Impurities (Andreas Richter and Bettina Katterle).
13.2 Potential Risks Associated with Impurities and Contaminants.
13.3 Safety Concepts and Acceptance Limits for Impurities and Contaminants.
13.4 Strategies for the Removal of Impurities and Contaminants.
13.5 Assays to Quantify Residual Impurities and Contaminants.
14 High-throughput RNA Interference: Emerging Technology for Functional Genomics (Yerramilli V. B. K. Subrahmanyam, and Eric Lader).
14.2 RNAi: Current Understanding of the Process.
14.3 RNAi as a Technology in Functional Genomics.
14.4 siRNA Design.
14.5 Homology Analysis.
14.6 BLAST, Smith–Waterman and QIAGEN Homology Searches.
14.7 High-throughput Synthesis.
14.8 Genome-wide Synthetic siRNA Libraries: Content and Design Process.
14.9 Small-molecule Screening and Genome-wide RNAi Screens: The Difference.
14.10 Genome-wide siRNA Screens in Mammalian Systems.
14.11 siRNA Delivery and Monitoring Gene Knockdown.
14.12 Concluding Remarks.
15 Developing an Antibody Purifi cation Process (Alexander Jacobi, Christian Eckermann and Dorothee Ambrosius).
15.2 Approaches for Downstream Purification.
15.3 Integrated Development Strategy.
15.4 Future Perspectives.
15.5 Concluding Remarks.
16 The Many Ways to Purify Plasmid DNA: Choosing the Right Purifi cation Strategy Based on the Downstream Application (Thorsten Singer and Markus Müller).
16.2 Plasmid Purification Methods.
16.3 Plasmid and Propagation.
16.4 Quality Aspects and Analytical Issues.
16.5 Process-scale Plasmid Isolation for Pharmaceutical Applications.
16.6 Example of a cGMP pDNA Production Process.
17 Advanced Fractionation Methods and Analysis for Proteomics Applications (Scot Weinberger and Egisto Boschetti).
17.2 Proteome Complexity and Current Challenges.
17.3 Sample Prefractionation Methods.
17.4 Low-abundance Protein Focus.
17.5 Analytical Methods.
17.6 Future Prospects.
Part V Safety, Quality Control, Validation and Regulatory Considerations.
18 Biosafety (Yusuf Chisti).
18.2 Risk Assessment.
18.3 Containment Levels.
18.4 Risk Management.
18.5 Concluding Remarks.
19 The Manufacture of Gene Therapy Products and Viral Vaccines (Andrew Bailey).
19.2 The Regulatory Climate for the Production of Gene Therapy Materials.
19.3 Virus Vector Design Issues.
19.4 Cell-based Therapy Design Issues.
19.5 GMPs for Early-phase Manufacturing.
19.6 Quality Assurance/QC Testing of Cells and Vectors.
19.7 Vaccine-specific Production Issues.
19.8 Future Perspectives for Vaccine and Gene Therapy Products.
20 The Virus and Prion Safety of Biopharmaceuticals (Andrew Bailey).
20.2 Acceptability Criterion for Virus Contamination of Start Material.
20.3 Testing Strategies for Adventitious Agents.
20.4 Validation of Virus Inactivation and Removal.
20.5 Transmissible Spongiform Encephalopathies and Biopharmaceuticals.
20.6 Future Perspectives: More or Less Testing?
21 Protein Glycosylation: Analysis and Characterization (Susan T. Sharfstein and Jong Hyun Nam).
21.2 Overview of Protein Glycosylation.
21.3 Effects of Glycosylation on Proteins.
21.4 Techniques for Separating Glycoproteins and Glycopeptides.
21.5 Strategies for Analysis and Characterization of Glycans.
22 High-throughput Glycoanalysis for Use in Biopharmaceuticals Development and Manufacturing (Rakefet Rosenfeld, Revital Rosenberg, Roberto Olender, Inbar Plaschkes, David Dabush, Chanan Himmelfarb, Sabine Boehme, Kurt Forrer, and Ruth Ben-Yakar Maya).
22.2 Glycosylation and the Biopharmaceutical Industry.
22.3 Lectin Array Platform.
22.4 Glycoanalysis of Recombinant Monoclonal Antibodies.
22.5 Glycoanalysis Directly on Nonpurified Supernatant Samples.
23 Quality Control of Implantable Drug Delivery Systems (Steven S. Kuwahara).
23.2 Device-like Qualities.
23.3 Color and Physical Appearance.
23.4 Dissolution and Disintegration.
23.6 Matrix Problems.
Part VI Analytical Methods and Technologies.
24 Polymerase Chain Reaction (PCR): An Analytical Tool in Bioprocessing (Dirk Loeffert).
24.1 PCR: History and Principle.
24.2 Good Laboratory Practice.
24.3 Essential Components of the PCR.
24.4 Qualitative PCR.
24.5 Quantitative PCR.
24.6 Use of Real-time PCR for Quality Control in Bioprocessing and Therapeutics Development.
25 Electrokinetic Separations (Zaki Megeed, Kaushal Rege, Arul Jayaraman, and Martin L. Yarmush).
25.2 Gel Electrophoresis.
25.3 Capillary Electrophoresis (CE).
25.4 Microscale Electrophoresis.
26 Capillary Isoelectric Focusing Methods for Charge-based Analysis of Biotech Pharmaceutical Samples (Jiaqi Wu and Tiemin Huang).
26.2 Initial Conditions in cIEF Method Development.
26.3 Some Issues in Method Development.