Medicina

Available online at www.sciencedirect.com

The
Veterinary Journal
The Veterinary Journal 178 (2008) 7–20
www.elsevier.com/locate/tvjl

Review

Veterinary vaccine development from an industrial perspective
J.G.M. Heldens a,*, J.R. Patel b, N. Chanter c, G.J. ten Thij a, M. Gravendijck d,
V.E.J.C. Schijns e, A. Langen f, Th.P.M. Schetters g
a
Department for Virological R&D, NobilonInternational BV, Exportstraat 39b, 5830 AH Boxmeer, The Netherlands
JAS Biologicals Ltd., The Annex, Innes Building, The Centre for Veterinary Science, Madingley Road, CB3 0ES Cambridge, UK
c
Department for Bacteriological R&D, Intervet International BV, Milton Keynes, UK
d
Department for Regulatory Affairs, Intervet International BV, W. de Korverstraat 35, 5831 AN Boxmeer, The Netherlands
¨
eDepartment for Vaccine Technology and Immunology, Intervet International BV, W. de Korverstraat 35, 5831 AN Boxmeer, The Netherlands
¨
f
Department for Quality Operations, Nobilon International BV, Exportstraat 39b, 5830 AH Boxmeer, The Netherlands
g
Department for Parasitological R&D, Intervet International BV, W. de Korverstraat 35, 5831 AN Boxmeer, The Netherlands
¨
b

Accepted 12November 2007

Abstract
Veterinary vaccines currently available in Europe and in other parts of the world are developed by the veterinary pharmaceutical
industry. The development of a vaccine for veterinary use is an economic endeavour that takes many years. There are many obstacles
along the path to the successful development and launch of a vaccine. The industrial development of a vaccine forveterinary use usually
starts after the proof of concept that is based on robust academic research. A vaccine can only be made available to the veterinary community once marketing authorisation has been granted by the veterinary authorities.
This review gives a brief description of the regulatory requirements which have to be fulfilled before a vaccine can be admitted to the
market. Vaccineshave to be produced in a quality controlled environment to guarantee delivery of a product of consistent quality with
well defined animal and consumer safety and efficacy characteristics. The regulatory and manufacturing legislative framework in which
the development takes place is described, as well as the trend in developments in production systems. Recent developments in bacterial,
viral andparasite vaccine research and development are also addressed and the development of novel adjuvants that use the expanding
knowledge of immunology and disease pathology are described.
Ó 2007 Elsevier Ltd. All rights reserved.
Keywords: Vaccine; Industry; Regulatory; Good manufacturing practice (GMP)

Introduction
The industrial development of a veterinary vaccine starts
once the proof ofconcept has been established. Proof of
concept is based on robust academic exploration of fundamental science. The scientific literature has reported many
academic proofs of various novel vaccine concepts in
recent years. Industrial vaccine development programs
(see Table 1 for its phases) starts once this proof of concept
*

Corresponding author. Tel.: +31 485 585232; fax: +31 485 585445.
E-mailaddress: jacco.heldens@nobilonvaccines.com (J.G.M. Heldens).
1090-0233/$ - see front matter Ó 2007 Elsevier Ltd. All rights reserved.
doi:10.1016/j.tvjl.2007.11.009

has been demonstrated and should eventually lead to market authorisation (MA), i.e. the permission to place a vaccine on the market, which is granted by the appropriate
veterinary authorities.
In contrast to academic proof ofconcept demonstrations, the industrial development of a vaccine should be
seen in an economic context. Veterinary vaccines are produced and marketed by pharmaceutical companies which
are in competition with one another. For veterinary vaccines there are two main target markets that can be recognised each with its own dynamics. These markets are (1) the
agricultural or production animal sector...