title: Inactivated polio vaccine development for technology transfer using attenuated Sabin poliovirus strains to shift from Salk-IPV to Sabin-IPV.
abstract: Industrial-scale inactivated polio vaccine (IPV) production dates back to the 1960s when at the Rijks Instituut voor de Volksgezondheid (RIV) in Bilthoven a process was developed based on micro-carrier technology and primary monkey kidney cells. This technology was freely shared with several pharmaceutical companies and institutes worldwide. In this contribution, the history of one of the first cell-culture based large-scale biological production processes is summarized. Also, recent developments and the anticipated upcoming shift from regular IPV to Sabin-IPV are presented. Responding to a call by the World Health Organization (WHO) for new polio vaccines, the development of Sabin-IPV was continued, after demonstrating proof of principle in the 1990s, at the Netherlands Vaccine Institute (NVI). Development of Sabin-IPV plays an important role in the WHO polio eradication strategy as biocontainment will be critical in the post-OPV cessation period. The use of attenuated Sabin strains instead of wild-type Salk polio strains will provide additional safety during vaccine production. Initially, the Sabin-IPV production process will be based on the scale-down model of the current, and well-established, Salk-IPV process. In parallel to clinical trial material production, process development, optimization and formulation research is being carried out to further optimize the process and reduce cost per dose. Also, results will be shown from large-scale (to prepare for future technology transfer) generation of Master- and Working virus seedlots, and clinical trial material (for phase I studies) production. Finally, the planned technology transfer to vaccine manufacturers in low and middle-income countries is discussed.
authors.affiliation: National Institute for Public Health and the Environment, Vaccinology unit, P.O. Box 1, 3720BA Bilthoven, The Netherlands. wilfried.bakker@rivm.nl
authors.forename: Wilfried A M
authors.initials: WA
authors.lastname: Bakker
authors.forename: Yvonne E
authors.initials: YE
authors.lastname: Thomassen
authors.forename: Aart G
authors.initials: AG
authors.lastname: van't Oever
authors.forename: Janny
authors.initials: J
authors.lastname: Westdijk
authors.forename: Monique G C T
authors.initials: MG
authors.lastname: van Oijen
authors.forename: Lars C
authors.initials: LC
authors.lastname: Sundermann
authors.forename: Peter
authors.initials: P
authors.lastname: van't Veld
authors.forename: Eelco
authors.initials: E
authors.lastname: Sleeman
authors.forename: Fred W
authors.initials: FW
authors.lastname: van Nimwegen
authors.forename: Ahd
authors.initials: A
authors.lastname: Hamidi
authors.forename: Gideon F A
authors.initials: GF
authors.lastname: Kersten
authors.forename: Nico
authors.initials: N
authors.lastname: van den Heuvel
authors.forename: Jan T
authors.initials: JT
authors.lastname: Hendriks
authors.forename: Leo A
authors.initials: LA
authors.lastname: van der Pol
mesh_terms: D000818:Animals; D002460:Cell Line; D000882:Haplorhini; D006801:Humans; D009426:Netherlands; D017955:Poliovirus / Q000235:genetics* / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated / Q000276:immunology*; D011055:Poliovirus Vaccine, Oral / Q000276:immunology*; D018581:Technology Transfer; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D011054:Poliovirus Vaccine, Inactivated; D011055:Poliovirus Vaccine, Oral