1.

Record Nr.

UNINA9910815553103321

Titolo

Vaccine development and manufacturing / / edited by Emily P. Wen, Ronald Ellis, Narahari S. Pujar ; Michel Chartrain [and thirty one others], contributors

Pubbl/distr/stampa

Hoboken, New Jersey : , : Wiley, , 2015

©2015

ISBN

1-78684-221-1

1-118-87090-5

1-118-87091-3

1-118-87092-1

Descrizione fisica

1 online resource (1044 p.)

Collana

Wiley Series in Biotechnology and Bioengineering

Disciplina

615.3/72

Soggetti

Vaccines

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references at the end of each chapters and index.

Nota di contenuto

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 Platform2.1 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 Production3.1 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 Introduction5.2 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 Technology7.2 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

Sommario/riassunto

Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high