Animal Welfare Aspects in the Quality Control of Immunobiologicals

Translation: Marlies Halder (ECVAM)

Editor: Krys Bottrill (FRAME)

The project was funded by: The Federal Ministry of Education, Science, Research and Technology (BMBF)

Project Leaders: K. Cußler and A. Zott.

Translation, editing and printing were sponsored by ECVAM, with the assistance of AMA Services.

Published in 1997 by FRAME for ECVAM and PEI

© FRAME

Design & Print by 4 Sheets, 245 Mansfield Road, Nottingham NG1 3FT, UK.

ISBN Number: 0 9501700 4 6

Foreward

Preface

Section 1: Introduction

Introduction

Section 2: Immunobiologicals for Human Use

I. Diphtheria Vaccine (Adsorbed)

II. Pertussis Vaccine (Adsorbed) and Pertussis Vaccine

III. Tetanus Vaccine (Adsorbed)

IV. Freeze-dried BCG Vaccine

V. Cholera Vaccine and Freeze-dried Cholera Vaccine

VI.Typhoid Vaccine and Freeze-dried Typhoid Vaccine

VII. Pyrogens (Methods of Analysis V.2.1.4)

VIII. Tuberculin Purified Protein Derivative for Human Use and Old Tuberculin for Human Use

IX. Poliomyelitis Vaccine (Inactivated)

X. Poliomyelitis Vaccine (Oral)

XI. Rabies Vaccine for Human Use Prepared in Cell Cultures

XII. Human Tetanus Immunoglobulin

XIII. Tetanus Antitoxin for Human Use

XIV. Diphtheria Antitoxin

XV. Botulinum Antitoxin

XVI. Gas-gangrene Antitoxins and Mixed Gas-gangrene Antitoxin

XVII. European Viper Venom Antiserum

Section 3: Immunobiologicals for Veterinary Use

XVIII. The Safety Test

XIX. Vaccines and Immunosera for Pigs

XX. Vaccines and Immunosera for Ruminants

XXI. Vaccines and Antitoxins for Horses

XXII. Vaccines for Dogs, Cats, Ferrets and Minks, and Foxes

XXIII. Vaccines for Poultry

XXIV. Tuberculins for Veterinary Use