Document Detail


Inactivated polio vaccine development for technology transfer using attenuated Sabin poliovirus strains to shift from Salk-IPV to Sabin-IPV.
MedLine Citation:
PMID:  21651934     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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 Salk-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:
Wilfried A M Bakker; Yvonne E Thomassen; Aart G Van't Oever; Janny Westdijk; Monique G C T van Oijen; Lars C Sundermann; Peter Van't Veld; Eelco Sleeman; Fred W van Nimwegen; Ahd Hamidi; Gideon F A Kersten; Nico van den Heuvel; Jan T Hendriks; Leo A van der Pol
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-6-4
Journal Detail:
Title:  Vaccine     Volume:  -     ISSN:  1873-2518     ISO Abbreviation:  -     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-6-9     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8406899     Medline TA:  Vaccine     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011. Published by Elsevier Ltd.
Affiliation:
Netherlands Vaccine Institute, P.O. Box 457, 3720AL Bilthoven, The Netherlands.
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