Vaccine Development and Manufacturing.

Cover -- Series -- Title Page -- Copyright -- Acknowledgments -- Preface -- Contributors -- Chapter 1: History of Vaccine Process Development -- 1.1 Introduction -- 1.2 Vaccines Bioprocess Evolution -- 1.3 Live Attenuated and Inactivated Virus Vaccines -- 1.4 Live or Whole-Killed Bacterial Vaccines -- 1.5 Classical Subunit Vaccines -- 1.6 Recombinant Subunit Vaccines -- 1.7 Conjugate Vaccines -- 1.8 Downstream Processing -- 1.9 Vaccines for the Developing World: Large Volume, Low Cost, and Thermostable -- 1.10 Summary -- Acknowledgments -- References -- Chapter 2: The Production of Plasmid DNA Vaccine in Escherichia coli: A Novel Bacterial-Based Vaccine Production Platform -- 2.1 Introduction: E. coli in Vaccine Production -- 2.2 Brief Overview of DNA Vaccines: Mechanisms and Methods of Vaccinations -- 2.3 Current Status of DNA Vaccines -- 2.4 Required Physical Properties of Plasmid DNA Vaccines -- 2.5 Choice of E. coli Host Strain -- 2.6 Factors Influencing Plasmid Stability -- 2.7 Transformation, Selection of Producing Clones, and Cell Banking -- 2.8 Production Process -- 2.9 Requirements for Clinical Supplies -- 2.10 Conclusions -- References -- Chapter 3: Fungal Expression Systems for Vaccine Production -- 3.1 Introduction -- 3.2 Hepatitis B Vaccines -- 3.3 Human Papillomavirus Vaccine -- 3.4 Malaria Vaccine Candidates -- 3.5 HIV Vaccine Candidates -- 3.6 Veterinary Vaccines -- 3.7 Perspectives -- 3.8 Concluding Remarks -- Acknowledgments -- References -- Chapter 4: Novel Expression Systems for Vaccine Production -- 4.1 Introduction -- 4.2 Subunit Vaccines -- 4.3 Expression Systems -- 4.4 Novel Expression Systems -- 4.5 Production of Recombinant Proteins in Plants -- 4.6 Launch Vector System -- 4.7 Conclusions -- References -- Chapter 5: Viral Vaccines Purification -- 5.1 Introduction -- 5.2 Process Tasks -- 5.3 Conclusions and Outlook.

Acknowledgments -- Nomenclature -- Abbreviations -- References -- Chapter 6: Protein Subunit Vaccine Purification -- 6.1 Introduction -- 6.2 Purification Technologies-Applications in Protein Subunit Vaccine Purification -- 6.3 Purification Process Development and Scale-Up for Protein Subunit Vaccine -- 6.4 Process Definition Studies -- 6.5 Process Economy and Automation -- 6.6 Application of Process Analytical Technology in Protein Purification -- 6.7 Downstream Purification-An Outlook -- References -- Chapter 7: Conjugate Vaccine Production Technology -- 7.1 Conjugate Vaccine Production Technology -- 7.2 Preparation of Antigen and Carrier Protein -- 7.3 Polysaccharide Size -- 7.4 Activation and Coupling of Polysaccharide and Carrier Protein -- 7.5 Characterization of the Conjugate -- 7.6 Future Directions -- References -- Chapter 8: Stabilization and Formulation of Vaccines -- 8.1 Introduction -- 8.2 An Example of a Modern Vaccine Characterization Strategy -- 8.3 A Comprehensive Approach to Vaccine Formulation in Practice -- 8.4 Conclusions -- References -- Chapter 9: Lyophilization In Vaccine Processes -- 9.1 Introduction -- 9.2 Formulation -- 9.3 Filling -- 9.4 Lyophilization -- 9.5 Equipment -- 9.6 Conclusions -- References -- Chapter 10: Strategies for Heat-Stable Vaccines -- 10.1 Introduction: Importance of Stable Vaccines -- 10.2 Stability of Current Vaccines -- 10.3 Vaccine Stabilization Strategies -- 10.4 Future of Vaccine Stabilization -- References -- Chapter 11: Production And Characterization Of Aluminum-Containing Adjuvants -- 11.1 Structure -- 11.2 Properties -- 11.3 Production -- 11.4 Characterization -- 11.5 Summary -- References -- Chapter 12: The Biologics License Application (BLA) in Common Technical Document (CTD) Format -- 12.1 Introduction -- 12.2 Organization of the Biologics Licensing Application.

12.3 Hints for Preparing the Biological Licensing Application -- References -- Chapter 13: The Original New Drug Application (Investigational New Drug) -- 13.1 Introduction -- 13.2 Format for Submitting an IND -- 13.3 Detailed Discussion of Information Required in the Chemistry Manufacturing and Control Sections -- 13.4 General Overview of Information Required in the Regional, Nonclinical, and Clinical Items -- References -- Chapter 14: Facility Design for Vaccine Manufacturing-Regulatory, Business, and Technical Considerations and a Risk-Based Design Approach -- 14.1 Introduction -- 14.2 Regulatory Considerations -- 14.3 The Business Context -- 14.4 Vaccine Manufacturing Facility-Overview -- 14.5 Expectations for Design of Vaccine Facilities -- 14.6 Risk-Based Principles for Design of Vaccine Facilities -- 14.7 Conclusions -- References -- Chapter 15: Vaccine Production Economics -- 15.1 Introduction -- 15.2 Vaccine Manufacturing, History, and Drivers -- 15.3 The Importance of Capital in Biologic Manufacturing -- 15.4 Process Design and Optimization -- 15.5 Process Development Knowledge Management-Capturing the Data -- 15.6 Modeling Approaches -- 15.7 Cost Models in Practice -- 15.8 Conclusions -- Acknowledgments -- References -- Index -- End User License Agreement.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.