Production, testing and perspectives of IPV and IPV combination vaccines: GSK biologicals' view.
GSK Biologicals has been involved in the production of Polio vaccine since the early start of Polio vaccination, beginning with the first generation of Inactivated Polio Vaccine (IPV). Over time, the company has developed solid industrial experience and knowledge that significantly contributes today to the quality of our Polio vaccines. GSK Biologicals' current IPV is now routinely produced according to the process defined by Van Wezel (RIVM) in the late seventies, using Vero cells and micro-carrier technology in bioreactors. In addition to compliance with current requirements (World Health Organization, European Pharmacopoeia, Code of Federal Regulations USA), the quality of the routine vaccine is guaranteed by numerous additional data related to the characterization, to the consistency, and to the validation of the process and the testing. This supplementary data package will allow, for instance, for the application of the in vitro potency testing for routine release instead of the in vivo testing. The present views on the Polio vaccine strategy for the post eradication era have portrayed a very limited role for the current IPV. The main reasons relate to post-eradication bio-containment needs and to production capacity and costs. A reevaluation of the classic approach taken to the use of the current IPV produced from wild type polio strains positions this vaccine as a real alternative to other strategies, allowing us to take advantage of the excellent performance of IPV over many years.
Duchêne
Michel
M
GlaxoSmithKline Biologicals, Rue de l'Institut 89, Rixensart 1330, Belgium. michel.duchene@gskbio.com