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Development of thermostable lyophilized inactivated polio vaccine.

Kraan H, van Herpen P, Kersten G, Amorij JP - Pharm. Res. (2014)

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

View Article: PubMed Central - PubMed

Affiliation: Institute of Translational Vaccinology (Intravacc), Antonie van Leeuwenhoeklaan 9, P.O. Box 450, 3720 AL, Bilthoven, The Netherlands.

ABSTRACT

Purpose: 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.

Conclusion: 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.

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Related in: MedlinePlus

DU recoveries of the best formulations from the screening experiment based on recoveries directly after lyophilization (>60% for all serotypes). Panel (a) shows the DU recoveries directly after lyophilization. Panel (b, c and d) show the recoveries after incubation for 1 week at 45°C, 2 weeks at 37°C, and 4 weeks at room temperature, respectively. The formulations are described in Table I.
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Fig3: DU recoveries of the best formulations from the screening experiment based on recoveries directly after lyophilization (>60% for all serotypes). Panel (a) shows the DU recoveries directly after lyophilization. Panel (b, c and d) show the recoveries after incubation for 1 week at 45°C, 2 weeks at 37°C, and 4 weeks at room temperature, respectively. The formulations are described in Table I.

Mentions: aFormulation selected for stability testing (as shown in Fig. 3)


Development of thermostable lyophilized inactivated polio vaccine.

Kraan H, van Herpen P, Kersten G, Amorij JP - Pharm. Res. (2014)

DU recoveries of the best formulations from the screening experiment based on recoveries directly after lyophilization (>60% for all serotypes). Panel (a) shows the DU recoveries directly after lyophilization. Panel (b, c and d) show the recoveries after incubation for 1 week at 45°C, 2 weeks at 37°C, and 4 weeks at room temperature, respectively. The formulations are described in Table I.
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4197379&req=5

Fig3: DU recoveries of the best formulations from the screening experiment based on recoveries directly after lyophilization (>60% for all serotypes). Panel (a) shows the DU recoveries directly after lyophilization. Panel (b, c and d) show the recoveries after incubation for 1 week at 45°C, 2 weeks at 37°C, and 4 weeks at room temperature, respectively. The formulations are described in Table I.
Mentions: aFormulation selected for stability testing (as shown in Fig. 3)

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

View Article: PubMed Central - PubMed

Affiliation: Institute of Translational Vaccinology (Intravacc), Antonie van Leeuwenhoeklaan 9, P.O. Box 450, 3720 AL, Bilthoven, The Netherlands.

ABSTRACT

Purpose: 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.

Conclusion: 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.

Show MeSH
Related in: MedlinePlus