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If the antibody industry is to achieve its full potential in the next decade, the individual technical potentials must be exploited, the limitations must be addressed, and lessons learned must be applied both to current purification methods and to the new technologies that continue to emerge. This book presents an overview of the current advances applied in the manufacture of monoclonal antibody including:
-concepts in development of manufacturing strategies,
-importance of antibody fragments,
-application of chromatography method development,
-quality control,
-effect of expression on antibody properties,
-virus removal and safety,
-pharmacokinetics,
-regulatory aspects.
List of contents
1. Concepts in Development of Manufacturing Strategies for Monoclonal Antibodies.- 2. Antibody Fragments: Production, Purification and Formatting for Therapeutic Applications.- 3. Large Scale Production of Therapeutic Antibodies: Considerations for Optimizing Product Capture and Purification.- 4. Scale-Up of Antibody Purification. From Laboratory Scale to Production.- 5. Purification of Antibody by Chromatographic Methods.- 6. Quality Control of Antibodies for Human Use.- 7. Expression of Human Anti Rh(D) Monoclonal Antibodies into Different Cell lines: Influence on their Functional Properties.- 8. Monoclonal Antibody Production: Minimising Virus Safety Issues.- 9. Contract Manufacturing of Biopharmaceutical Grade Antibodies.- 10. The Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies.- 11. Regulatory and Legal Requirements for the Manufacture of Antibodies.
Summary
If the antibody industry is to achieve its full potential in the next decade, the individual technical potentials must be exploited, the limitations must be addressed, and lessons learned must be applied both to current purification methods and to the new technologies that continue to emerge. This book presents an overview of the current advances applied in the manufacture of monoclonal antibody including:
-concepts in development of manufacturing strategies,
-importance of antibody fragments,
-application of chromatography method development,
-quality control,
-effect of expression on antibody properties,
-virus removal and safety,
-pharmacokinetics,
-regulatory aspects.
