FAO ANIMAL PRODUCTION AND HEALTH PAPER 87
Manual for the production of anthrax and blackleg vaccines | |
by
Dr R.P. Misra
The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United Nations concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.
M-27
ISBN 92-5-102920-2
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying or otherwise, without the prior permission of the copyright owner. Applications for such permission, with a statement of the purpose and extent of the reproduction, should be addressed to the Director, Publications Division, Food and Agriculture Organization of the United Nations, Via delle Terme di Caracalla, 00100 Rome, Italy.
This manual provides a comprehensive description of standard methods for the production of vaccines against anthrax and blackleg. All steps of the procedure are taken up, from the choice of a vaccine strain to the shipping of the final product, with all relevant technical details. We have chosen to treat anthrax and blackleg vaccines in a single manual because the two diseases bear significant similarities. They are both multispecies diseases caused by spore-forming bacteria. Spores enable organisms to survive for long periods in the natural environment and particularly in soil which is a natural reservoir for both diseases.
The general methodology of vaccine production is also similar for those two organisms. In both cases the original vaccine strain can release its immunogenic properties upon repeated subcultures so that it is necessary to use a “seed system” strategy, whereby the master seed-lot is controlled for efficacy before further processing. At last both types of vaccines are evaluated for both potency and innocuity in laboratory animal models, according to standardized protocols. However, the anthrax vaccine is made from spores of an attenuated strain, whereas blackleg vaccine contains formalized cultures of a virulent strain.
We hope that this manual will assist vaccine production units of developing countries in manufacturing anthrax and blackleg vaccines of high quality standards.
FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS
Rome, © FAO 1991
Hyperlinks to non-FAO Internet sites do not imply any official endorsement of or responsibility for the opinions, ideas, data or products presented at these locations, or guarantee the validity of the information provided. The sole purpose of links to non-FAO sites is to indicate further information available on related topics.
Part I
PRODUCTION OF ANTHRAX SPORE VACCINE
Precautions and laboratory discipline
Media for testing bacterial contamination
Strains for testing potency
Guinea pig challenge strain (17 JB)
Virulent strain
PREPARATION AND CONTROL OF VACCINE SEED-LOTS
Preparation of master seed-lot
Preparation of working seed-lot
Control of seed-lot
Tests for bacterial contamination
Safety test
Immunogenicity test
PREPARATION AND CONTROL OF
VACCINE CONCENTRATE
Preparation of vaccine concentrate
Inoculation
Harvesting
Purity test
Glycerination
Control tests on vaccine concentrate
Tests for bacterial contamination
Test for number of culturable spores
Safety test
Potency test
Dilution of vaccine concentrate
CONTROL TESTS ON FINAL PRODUCT
Inspection of final containers
Identity test and tests for absence of bacterial contamination
Test for number of culturable spores
Residual moisture content for freeze-dried vaccine
Records of seed-lots and cultures
Production protocol and distribution records
INSTRUCTIONS FOR USE OF VACCINE
Appendix 2
Procedure for detection of motility
of organisms
Appendix 3
Stabilizers for freeze-drying
Appendix 4
Procedure for viable spore count
Appendix 5
Summary protocol for production
and control of anthrax spore vaccine, living
Part II
PRODUCTION OF BLACKLEG VACCINE
Precautions and laboratory discipline
Semi-synthetic anaerobic medium
Isolation
Sampling
Isolation methods
Propagation of strain in animals
Preservation of strain
Vegetative organisms
Spores
Determination of 50-percent lethal dose (LD 50) of freeze-dried spores
PREPARATION AND CONTROL OF VACCINE SEED-LOTS
Preparation of master seed-lot
Preparation of working seed-lot
Control of seed-lot
Tests for bacterial contamination
Safety test
Immunogenicity test
Adjuvants and concentration
Alum
Aluminium hydroxide gel
CONTROL TESTS ON FINAL PRODUCT
Inspection of final containers
Records of seed-lots and cultures
Production protocol and distribution records
INSTRUCTIONS FOR USE OF VACCINE
Appendix 2
Stabilizers for freeze-drying
Appendix 3
Summary protocol for production
and control of Clostridium chauvoei
(blackleg) vaccine