Development of thermostable lyophilized inactivated polio vaccine.
OBJECTIVE
The aim of current study was to develop a dried inactivated polio vaccine (IPV) formulation with minimal loss during the drying process and improved stability when compared with the conventional liquid IPV.


METHODS
Extensive excipient screening was combined with the use of a Design of Experiment (DoE) approach in order to achieve optimal results with high probability.


RESULTS
Although it was shown earlier that the lyophilization of a trivalent IPV while conserving its antigenicity is challenging, we were able to develop a formulation that showed minimal loss of potency during drying and subsequent storage at higher temperatures.


CONCLUSIONS
This study showed the potential of a highly stable and safe lyophilized polio vaccine, which might be used in developing countries without the need of a cold-chain.
Institute of Translational Vaccinology (Intravacc), Antonie van Leeuwenhoeklaan 9, P.O. Box 450, 3720 AL, Bilthoven, The Netherlands.
Heleen
H
Kraan
Paul
P
van Herpen
Gideon
G
Kersten
Jean-Pierre
JP
Amorij
D002626:Chemistry, Pharmaceutical; D004355:Drug Stability; D005079:Excipients / Q000737:chemistry; D005612:Freeze Drying; D010316:Particle Size; D017955:Poliovirus / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated / Q000737:chemistry* / Q000276:immunology; D011055:Poliovirus Vaccine, Oral / Q000737:chemistry* / Q000276:immunology; D013678:Technology, Pharmaceutical / Q000379:methods*; D013696:Temperature; D044366:Transition Temperature
D005079:Excipients; D011054:Poliovirus Vaccine, Inactivated; D011055:Poliovirus Vaccine, Oral