Journal
VACCINE
Volume 20, Issue 19-20, Pages 2411-2430Publisher
ELSEVIER SCI LTD
DOI: 10.1016/S0264-410X(02)00192-5
Keywords
good manufacturing practice; vaccine; potency; animal use; quality control
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In vivo assays play a crucial role in the assessment of the potency and safety of human vaccines. Robust vaccine production procedures, improved characterisation methods and development of well-characterised vaccines create possibilities to reduce animal use. In this paper the current status in this field is reviewed. Achievements with regard to in vivo and in vitro potency and safety testing are discussed as well as new developments and possibilities in the field of in vitro characterisation of vaccine components. Finally, validation and implementation issues will be dealt with. Although replacement of in vivo tests for batch release of existing vaccines is difficult, emerging technologies allow well-considered reduction of in vivo experiments during product and process development and improvement. Inextricably bound up with this approach is good manufacturing practice (GMP), resulting in robust, validated production processes. (C) 2002 Elsevier Science Ltd. All rights reserved.
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