title: Next generation inactivated polio vaccine manufacturing to support post polio-eradication biosafety goals.
abstract: Worldwide efforts to eradicate polio caused a tipping point in polio vaccination strategies. A switch from the oral polio vaccine, which can cause circulating and virulent vaccine derived polioviruses, to inactivated polio vaccines (IPV) is scheduled. Moreover, a manufacturing process, using attenuated virus strains instead of wild-type polioviruses, is demanded to enhance worldwide production of IPV, especially in low- and middle income countries. Therefore, development of an IPV from attenuated (Sabin) poliovirus strains (sIPV) was pursued. Starting from the current IPV production process based on wild type Salk strains, adaptations, such as lower virus cultivation temperature, were implemented. sIPV was produced at industrial scale followed by formulation of both plain and aluminium adjuvanted sIPV. The final products met the quality criteria, were immunogenic in rats, showed no toxicity in rabbits and could be released for testing in the clinic. Concluding, sIPV was developed to manufacturing scale. The technology can be transferred worldwide to support post polio-eradication biosafety goals.
authors.affiliation: Institute for Translational Vaccinology (Intravacc), Bilthoven, The Netherlands.
authors.forename: Yvonne E
authors.initials: YE
authors.lastname: Thomassen
authors.affiliation: Institute for Translational Vaccinology (Intravacc), Bilthoven, The Netherlands.
authors.forename: Aart G
authors.initials: AG
authors.lastname: van 't Oever
authors.affiliation: Institute for Translational Vaccinology (Intravacc), Bilthoven, The Netherlands.
authors.forename: Monique G C T
authors.initials: MG
authors.lastname: van Oijen
authors.affiliation: Bioprocess Engineering, Wageningen University, Wageningen, The Netherlands.
authors.forename: René H
authors.initials: RH
authors.lastname: Wijffels
authors.affiliation: Institute for Translational Vaccinology (Intravacc), Bilthoven, The Netherlands.
authors.forename: Leo A
authors.initials: LA
authors.lastname: van der Pol
authors.affiliation: Institute for Translational Vaccinology (Intravacc), Bilthoven, The Netherlands.
authors.forename: Wilfried A M
authors.initials: WA
authors.lastname: Bakker
mesh_terms: D000818:Animals; D002522:Chlorocebus aethiops; D006168:Guinea Pigs; D051379:Mice; D011051:Poliomyelitis / Q000276:immunology / Q000517:prevention & control*; D017955:Poliovirus / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated / Q000276:immunology / Q000494:pharmacology; D011817:Rabbits; D051381:Rats; D064166:Vaccine Potency; D014709:Vero Cells
chemical_list: D011054:Poliovirus Vaccine, Inactivated