Vaccine manual: The production and quality control of veterinary vaccines for use in developing countries


VACCINE MANUAL

The production and quality control of veterinary vaccines for use in developing countries

 

 

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Table of Contents

Introduction

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PART I
The induction of immunity by veterinary immunoprophylactics
Genetically engineered vaccines Viral vaccines
Bacterial vaccines
Mycoplasmal vaccines
Protozoal and rickettsial vaccines
Multicellular parasite vaccines
Conventional vaccines
Special requirements for village chickens
Fish vaccines
Role of the Office International des Epizooties and International organizations in vaccine quality standardization

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PART II
Registration, licensing, controls and practical issues related to veterinary vaccines
The role of private industry in the transfer of vaccine technology to developing countries
General design and operating requirements for vaccine manufacturing establishments
Design, repair and maintenance of vaccine manufacturing establishments and equipment
Aspects of financial management of veterinary vaccine manufacturing operations in developing countries
The logistics of vaccine manufacture in developing countries

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PART III
Basic laboratory services and media preparation for vaccine produtcion
Modern cell culture technology for vaccine manufacture
Fermentation technology for the production of bacterial vaccines
The use of lyophilization in the manufacture of vaccines
Viral vaccines
Bacterial vaccines
Adjuvants in veterinary vaccines
Bottling, labelling and packaging of vaccines

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PART IV
Quality assurance and good manufacturing practice
The principles of good laboratory practices , including safety in vaccine production and quality control
The role of reference and regional laboratories
Description and documnetation of production and quality control of veterinary vaccines
Assessment of potency in bacterial vaccines
Potency control of modified live viral vaccines
Potency assessment of inactivated viral vaccines
In vitro potency testing of inactivated biologics: current situation in the European Union
Sterility management and testing of vaccines and raw materials for adventitious agents

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Contributors

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The designations employed and the presentation of material in this information product do not imply the expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United Nations or its partners concerning the legal or development status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The views expressed in this publication are those of the authors and do not necessarily reflect the views of the Food and Agriculture Organization of the United Nations or its partners. The conclusions given in this report are considered appropriate at the time of its preparation.

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