Reduction of animal use in human vaccine quality control: opportunities and problems

Publication Type:

Journal Article


Vaccine, Volume 20, Number 19-20, pp. 2411-2430 (2002)



DOI Name (links to online publication)


good manufacturing practice; vaccine; potency; animal use; quality control; influenzae type-b; anion-exchange chromatography; pulsed-amperometric detection; surface-plasmon resonance; vi capsular polysaccharide; mass-transport limitation; toxicity test pr


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.