New Approaches to Stabilisation of Vaccines Potency: Who Headquarters, May 1995 / Edition 1

New Approaches to Stabilisation of Vaccines Potency: Who Headquarters, May 1995 / Edition 1

by Fred Brown
     
 

ISBN-10: 3805563094

ISBN-13: 9783805563093

Pub. Date: 07/28/1996

Publisher: Karger, S. Inc.

Immunization is one of the most important tools in public health and, according to the World Bank, the most cost-effective intervention in medicine. Vaccines have to be developed, field-tested, licensed, produced, quality controlled, regulated, purchased, transported, stored and delivered. Vaccine stability is a crucial factor to ensure that the vaccine delivered to…  See more details below

Overview

Immunization is one of the most important tools in public health and, according to the World Bank, the most cost-effective intervention in medicine. Vaccines have to be developed, field-tested, licensed, produced, quality controlled, regulated, purchased, transported, stored and delivered. Vaccine stability is a crucial factor to ensure that the vaccine delivered to the child is safe and effective. This book reports the proceedings of an international conference organized by the International Association of Biological Standardization and representatives of WHO's Global Programme for Vaccines and Immunization to discuss technical and regulatory aspects of vaccine stability and ways to improve collaboration. Topics under consideration include vaccine transport and storage; problems with maintaining the cold chain, especially in developing countries; reasons for instability of existing vaccines, and recent developments in the design of viral, bacterial and parasite vaccines. The factors affecting vaccine stability are evaluated, and a large number of new approaches for vaccine stabilisation are presented. Comprehensive and up-to-date, this publication will be appreciated by anyone concerned with the development, production and distribution of vaccines.

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Product Details

ISBN-13:
9783805563093
Publisher:
Karger, S. Inc.
Publication date:
07/28/1996
Series:
Developments in Biological Standardizati
Pages:
364

Table of Contents

Keynote Address1
Current Requirements and Strategies for Vaccine Stabilisation7
Vaccine Transport and Storage: Environmental Challenges9
Vaccine Stability in the Context of Vaccine Delivery in a Developing Country: India19
Problems Encountered in the Delivery and Storage of OPV in an African Country27
Experience with Veterinary Vaccines in Warm Climates33
Will Stability Remain an Issue for 21st Century Vaccines?43
Research Priorities for the WHO Global Programme for Vaccines and Immunization45
Recent Developments in the Design of Viral Vaccines51
Recent Trends in the Developments of Bacterial Vaccines59
Progress on Vaccines Against Parasites73
Developments in Immunization Practices and Strategies: Implications for Vaccine Stability85
Reasons for Instability of Existing Vaccines95
Factors Affecting the Stability of Viral Vaccines97
Stabilising Oral Poliovaccine at High Ambient Temperatures103
Reasons for Instability of Bacterial Vaccines113
The Reaction of Bacterial Toxins with Formaldehyde and its Use for Antigen Stabilization125
Analysis of Vaccine Stability135
Physicochemical Studies of the Structure and Stability of Polysaccharide-Protein Conjugate Vaccines143
New Approaches to Vaccine Stabilisation (1)153
Thermostability of Poliovirus and Measles Vaccines155
The Replacement of Water with Deuterium Oxide Significantly Improves the Thermal Stability of the Oral Poliovirus Vaccine161
A Varicella Vaccine Stable at 5[degree]C167
Stabilisation of Poliovirus with Pirodavir173
Regulatory Considerations for New Stabilised Poliovaccines181
New Approaches to Vaccine Stabilisation (2)191
Stabilisation of Vaccines Using Trehalose (Q-T4) Technology193
Potential of Chimaeric Plant Virus Particles as Novel, Stable Vaccines201
Protein Stabilisation Using Additives Based on Multiple Electrostatic Interactions207
Stability of Yellow Fever Vaccine219
Poster Session227
Vaccine Stability not by Eliminating Thermolability but through the Environmental Stability229
Biodegradable Microparticles as Parenteral Vaccine Delivery Systems231
New Approaches to Vaccine Stabilisation (3)233
Stabilization of Rinderpest Vaccine by Modification of the Lyophilization Process235
Stability of Recombinant Vaccinia-Rabies Vaccine in Veterinary Use245
Stabilisation of BCG Vaccines251
Stability Testing in Haemophilus Influenzae Type b Conjugate Vaccines263
Glycoconjugate Vaccines: Future Combinations269
Factors Influencing the Stability of Live Oral Attenuated Bacterial Vaccines277
Mimicry of Viral Epitopes with Retro-Inverso Peptides of Increased Stability283
Strategies for Stabilizing Tetanus Toxoid towards the Development of a Single-Dose Tetanus Vaccine293
Standardization of Vaccine Stability: Regulatory Issues307
Stability Testing Requirements for Vaccines - Draft Guidelines of the International Conference on Harmonization (ICH)309
Regulatory Requirements for Veterinary Vaccine Stability in the European Community319
Regulatory Practices and Problems with Vaccine Stability Studies and the Establishment of Shelf Lives329
General Discussion335
Summary and Conclusions337

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