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E-grāmata: Development of Vaccines: From Discovery to Clinical Testing

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  • Formāts: PDF+DRM
  • Izdošanas datums: 04-May-2011
  • Izdevniecība: John Wiley & Sons Inc
  • Valoda: eng
  • ISBN-13: 9781118023624
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Development of Vaccines: From Discovery to Clinical TestingPalielināt
  • Formāts: PDF+DRM
  • Izdošanas datums: 04-May-2011
  • Izdevniecība: John Wiley & Sons Inc
  • Valoda: eng
  • ISBN-13: 9781118023624
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Development of Vaccines: From Discovery to Clinical Testing outlines the critical steps, and analytical tools and techniques, needed to take a vaccine from discovery through a successful clinical trial. Contributions from leading experts in the critical areas of vaccine expression, purification, formulation, pre-clinical testing and regulatory submissions make this book an authoritative collection of issues, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section with details and real-life experiences of toxicology testing and regulatory filing for vaccines is also included.

Recenzijas

Given the scarcity of books on this topic, this title will be a welcome addition to those with an interest in vaccine development, mostly researchers and students.  It will be a useful reference for occupational health professionals whose role involves supervision of immunization programmes such as those working in the National Health Service, some sectors of higher education and the pharmaceutical industry.  (Journal of Occupational Medicine, 1 January 2013)

Preface ix
Contributors xi
PART 1 IMMUNOGEN DESIGN
1(94)
1 Microbial Vaccine Design: The Reverse Vaccinology Approach
3(16)
Roberto Rosini
Michele A. Barocchi
Rino Rappuoli
1.1 Introduction
3(1)
1.2 Historical View of "Classical" Vaccinology
4(2)
1.3 Reverse Vaccinology
6(6)
1.4 Vaccine Design: From Conventional Vaccinology to the Postgenomic Era Through Reverse Vaccinology
12(2)
1.5 Conclusions
14(5)
References
15(4)
2 Design And Development Of Recombinant Vaccines With Viral Properties
19(46)
Gerd Lipowsky
Martin F. Bachmann
2.1 Introduction
19(3)
2.2 Viral Properties and Immune Responses
22(9)
2.3 Translating Immunogenic Viral Properties into Rationally Designed Vaccines
31(14)
2.4 Conclusion
45(20)
References
45(20)
3 Tools For Vaccine Design: Prediction And Validation Of Highly Immunogenic And Conserved Class Ii Epitopes And Development Of Epitope-Driven Vaccines
65(30)
Anne S. De Groot
Matthew Ardito
Ryan Tassone
Paul Knopf
Leonard Moise
William Martin
3.1 Introduction
65(2)
3.2 Applying Immunoinformatics Tools to the Problem of Vaccine Design
67(1)
3.3 Epitope-Driven Approach to Vaccine Development
67(7)
3.4 Vaccine Design Tools
74(9)
3.5 Immunogenic Consensus Sequence (ICS) Vaccines
83(1)
3.6 ICS Protein-Based Vaccines
84(1)
3.7 Potential Pitfalls: Advantages and Disadvantages of IDV
84(11)
References
86(9)
PART 2 VACCINE PLATFORMS
95(166)
4 Virus-Like Particle Vaccines: Advantages And Challenges
97(28)
Ted M. Ross
Nitin Bhardwaj
Hermancia S. Eugene
Brendan M. Giles
Sean P. McBurney
Shannan L. Rossi
Kirsten Schneider-Ohrum
Xian-chun Tang
4.1 Introduction
97(3)
4.2 Human Papillomavirus
100(2)
4.3 HIV/AIDS
102(5)
4.4 Norovirus
107(1)
4.5 Influenza
108(3)
4.6 Flaviviruses
111(2)
4.7 Rift Valley Fever Virus
113(2)
4.8 Conclusions
115(10)
References
116(9)
5 Design Platforms Of Nanocapsules For Human Therapeutics Or Vaccines
125(16)
Masaaki Kawano
Li Xing
Kit S. Lam
Hiroshi Handa
Tatsuo Miyamura
Susan Barnett
Indresh K. Srivastava
R. Holland Cheng
5.1 Application of Virus-Like Particles for Vaccination
125(1)
5.2 Innate and Adaptive Cellular Immune Responses Against Virus-Like Particles
126(2)
5.3 Tailoring Virus-Like Particles by Altering the Capsid Surface for Vaccine Development
128(2)
5.4 Use of Fluorescent-Labeled Virus-Like Particles to Isolate Rotavirus-Specific B-Cell Clones for Human Monoclonal Antibody Production
130(1)
5.5 VLP Application as a Delivery Carrier
131(4)
5.6 Conclusion
135(6)
References
136(5)
6 Designing Immunogens For Vaccine Development In Reference To Hiv
141(44)
Aemro Kassa
Zohar Biron-Sorek
Pampi Sarkar
Indresh K. Srivastava
6.1 Summary
141(1)
6.2 Introduction
142(4)
6.3 HIV-1 Neutralizing Antibodies
146(8)
6.4 Challenges in Inducing Broadly Neutralizing Antibodies
154(1)
6.5 Current Strategies in Designing Immunogens to Induce Broadly Neutralizing Antibodies
155(30)
References
168(17)
7 Expression And Purification Of Recombinant Proteins For Vaccine Applications
185(30)
Carlo Zambonelli
Deeann Martinez-Guzmann
Indresh K. Srivastava
7.1 Protein Expression
186(2)
7.2 Prokaryotic Protein Expression Systems and Expression Vectors
188(1)
7.3 Escherichia coli
188(2)
7.4 Autoinduction
190(1)
7.5 Eukaryotic Expression Systems Yeasts
191(1)
7.6 Insect Cells
192(2)
7.7 Mammalian Cells
194(1)
7.8 Baby Hamster Kidney (BHK) Cells
194(1)
7.9 Human Cells
195(2)
7.10 Cell-Free Expression Systems
197(1)
7.11 Protein Refolding
197(1)
7.12 Protein Purification
198(17)
References
206(9)
8 Dna Vaccines For Infectious Diesase
215(28)
Samuel Stepenson
Manmohan Singh
Indresh K. Srivastava
8.1 Introduction
215(1)
8.2 Humoral Immune Responses
216(2)
8.3 Cytotoxic T-Cell Responses
218(2)
8.4 Protection by DNA Vaccines in Preclinical Disease Models
220(1)
8.5 Vector and Gene Optimization
221(2)
8.6 Adjuvants for DNA Vaccines
223(1)
8.7 Immunostimulatory Activity of DNA Vaccines
224(1)
8.8 DNA Vaccine Delivery Systems
224(1)
8.9 Physical Methods
225(1)
8.10 Particle-Mediated Delivery of DNA Vaccines
226(1)
8.11 Use of Live Viral and Bacterial Vectors for Vaccine Delivery
227(1)
8.12 Summary
227(16)
References
228(15)
9 Developing Stable Cell Lines For The Production Of Vaccine Antigens
243(18)
Xiaotian Zhong
Zhijian Lu
Richard Zollner
Jimin Zhang
Emily Braunstein
Narender Kalyan
Maninder Sidhu
9.1 Introduction
243(2)
9.2 Background, Methods, and Approaches---CHO Cell Recombinant Proteins
245(10)
9.3 Generation of Stable Cell Lines for the Production of Replication-Defective Viral Vaccines
255(1)
9.4 Conclusions
256(5)
References
257(4)
PART 3 CHARACTERIZATION OF IMMUNOGENS
261(44)
10 Spectroscopy Of Vaccines
263(30)
C. Russell Middaugh
Sangeeta B. Joshi
10.1 Introduction
263(1)
10.2 Spectroscopic Analyses
264(1)
10.3 Circular Dichroism
265(3)
10.4 Fourier Transform Infrared Spectroscopy
268(4)
10.5 Raman Spectroscopy
272(2)
10.6 Tertiary Structure
274(1)
10.7 Ultraviolet/Visible Absorption Spectroscopy
274(2)
10.8 Fluorescence Spectroscopy
276(4)
10.9 Other Methods to Detect Changes in Tertiary Structures
280(2)
10.10 Measurement of Dynamic Aspects of Vaccine Structure
282(1)
10.11 Analysis of Spectral Data
283(1)
10.12 Spectroscopy in the Presence of Adjuvants
284(3)
10.13 New Spectroscopic Approaches
287(1)
10.14 Conclusions
288(5)
References
288(5)
11 Biophysical Characterization Of Protein Antigens Within Vaccine Formulations
293(12)
Padma Malyala
Derek O'Hagan
Manmohan Singh
11.1 Introduction
293(1)
11.2 Chromatography-Based Methods
294(2)
11.3 Light-Based Methods
296(5)
11.4 Differential Scanning Calorimetry
301(1)
11.5 X-Ray Powder Diffractometry
301(1)
11.6 Summary
302(3)
References
302(3)
PART 4 FORMULATION OPTIMIZATION AND STABILITY EVALUATION
305(110)
12 Structural Characteristics Predict The Stability Of Hiv
307(20)
Zohar Biron-Sorek
Yide Sun
Elaine Kan
Jeanne Flandez
Michael Franti
Jeffrey Ulmer
Susan Barnett
Indresh K. Srivastava
12.1 Introduction
307(2)
12.2 Results
309(10)
12.3 Discussion
319(1)
12.4 Materials and Methods
320(1)
12.5 Circular Dichroism
321(1)
12.6 HPLC CD4 Binding Assay
321(1)
12.7 Differential Scanning Calorimetric Analysis of Proteins
321(1)
12.8 Hydrodynamic Radius Measurement
322(1)
12.9 Surface Plasmon Resonance Assay
322(5)
References
322(5)
13 Selection Of Optimal Adjuvants And Product Factors That Affect Vaccine Immunogenicity
327(58)
Wei Wang
Manmohan Singh
13.1 Introduction
327(1)
13.2 Vaccine-Induced Immunological Responses
328(2)
13.3 Aluminum Salts
330(7)
13.4 Nonaluminum Adjuvants
337(21)
13.5 Other Product-Related Factors
358(7)
13.6 Summary
365(20)
References
366(19)
14 Lyophilization And Stabilization Of Vaccines
385(14)
James Chesko
Chris Fox
Tim Dutill
Thomas Vedvick
Steve Reed
14.1 Introduction
385(1)
14.2 Lyophilization Process
386(1)
14.3 Examples of Progress in Creating Lyophilized Vaccines
387(2)
14.4 Current Research and Future Trends in Vaccine Lyophilization and Stabilization
389(1)
14.5 Conclusions
390(9)
References
390(9)
15 Effect Of Buffers And Stabilizers On Vaccine Stability And Efficacy
399(16)
Shireesh P. Apte
Sydney O. Ugwu
15.1 Mechanisms of Stabilization of Vaccines by Buffers/Stabilizers
399(4)
15.2 Effect of Excipients on Vaccine Efficacy
403(2)
15.3 Surfactant Effects
405(1)
15.4 Antioxidant Effects
405(1)
15.5 Preservative Effects
406(1)
15.6 Sugars
406(1)
15.7 Amino and Nucleic Acids
407(1)
15.8 Chelating Agent
408(1)
15.9 Polymeric Zwitterionic Buffers
408(1)
15.10 Abbreviations
409(6)
References
410(5)
PART 5 CLINICAL AND MANUFACTURING ISSUES
415(36)
16 Selection Of Final Product Containers
417(20)
Luis Baez
Adrian Distler
16.1 Introduction
417(1)
16.2 Container Systems
418(2)
16.3 Guidance and Recommendations from Industry and Regulatory Agencies
420(1)
16.4 Container Design and Selection
421(3)
16.5 Critical to Quality Attributes of the Product
424(2)
16.6 Prescreening or Developmental Studies
426(1)
16.7 Quality Throughout the Process
427(1)
16.8 Container System Components, Suppliers, and the Raw Material Network
428(4)
16.9 Container Development and Integrity Evaluation
432(5)
References
434(3)
17 From The Lab To The Clinic: Filing A Phase I Ind For An Investigational Vaccine
437(14)
Kenneth G. Surowitz
17.1 Introduction
437(1)
17.2 The Pre-IND Meeting
438(1)
17.3 Request Letter for a Pre-IND Meeting
439(1)
17.4 Pre-IND Meeting Package (Background Package)
440(1)
17.5 Conduct of the Pre-IND Meeting
441(1)
17.6 Filing the IND
442(1)
17.7 General Investigational Plan
443(1)
17.8 Investigator's Brochure
444(1)
17.9 Chemistry, Manufacturing, and Control (CMC) Information
445(2)
17.10 Pharmacology and Toxicology Information
447(1)
17.11 Other Information
448(1)
17.12 After Filing the IND
448(3)
References
449(2)
Index 451
Manmohan Singh, PhD, is currently working as the Global Head of Vaccine Formulation Science at Novartis Vaccines and Diagnostics in Cambridge, Massachusetts. Dr. Singh is a well-known expert in the areas of vaccine formulations and adjuvant research and has been working in vaccine R&D for the last twenty years. He has authored over 100 peer-reviewed manuscripts, review articles, and book chapters in this area. Dr. Singh is on the editorial board of seven international journals and has contributed to organizing several international vaccine conferences. He is also the editor of Vaccine Adjuvants and Delivery Systems (also published by Wiley). Indresh K. Srivastava, PhD, is recognized as an expert in the field of vaccine research, particularly immunogen design, purification, and characterization of vaccines. He has been working in the field for more than twenty-five years; has published more than seventy-five scientific papers in peer-reviewed journals; and authored several reviews and book chapters. In addition, he has served on NIH special emphasis study sections focused on HIV Vaccines. He is on the editorial board of Current HIV Research, and is reviewer for ten international journals. After spending more than twelve years at Chiron/Novartis, Dr. Srivastava has joined the Vaccine Research Institute, NIAID/NIH, to lead the purification and analytical development of vaccine candidates. Prior to joining Chiron, he was an assistant professor (research) in microbiology and immunology, Medical College of Pennsylvania, Philadelphia.
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