Skip to Content
MilliporeSigma

Development of thermostable lyophilized inactivated polio vaccine.

Pharmaceutical research (2014-04-25)
Heleen Kraan, Paul van Herpen, Gideon Kersten, Jean-Pierre Amorij
ABSTRACT

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. 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.

MATERIALS
Product Number
Brand
Product Description

Supelco
Electrolyte solution, nonaqueous, 2 M LiCl in ethanol
Supelco
Citric acid, Anhydrous, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Sucrose, SAJ first grade
Sigma-Aldrich
Citric acid, SAJ first grade, ≥99.5%
Sigma-Aldrich
Sucrose, JIS special grade
Supelco
Sucrose, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Magnesium chloride hexahydrate, tested according to Ph. Eur.
USP
Sucrose, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Sodium phosphate dibasic, BioUltra, Molecular Biology, ≥99.5% (T)
Sigma-Aldrich
Sodium phosphate dibasic, purum p.a., anhydrous, ≥98.0% (T)
Sigma-Aldrich
Citric acid, BioUltra, anhydrous, ≥99.5% (T)
Sigma-Aldrich
Citric acid, ACS reagent, ≥99.5%
Sigma-Aldrich
Magnesium chloride hexahydrate, BioUltra, Molecular Biology, ≥99.0% (KT)
Sigma-Aldrich
Magnesium chloride hexahydrate, BioXtra, ≥99.0%
Sigma-Aldrich
Sucrose, ≥99.5% (GC)
Sigma-Aldrich
Sucrose, ≥99.5% (GC)
Sigma-Aldrich
Sucrose, Molecular Biology, ≥99.5% (GC)
Supelco
Sucrose, analytical standard, for enzymatic assay kit SCA20
Sigma-Aldrich
Sodium phosphate dibasic, BioReagent, suitable for cell culture, suitable for insect cell culture, ≥99.0%
Sigma-Aldrich
Sodium phosphate dibasic, ReagentPlus®, ≥99.0%
Sigma-Aldrich
Sodium phosphate dibasic, BioXtra, ≥99.0%
Sigma-Aldrich
Sucrose, meets USP testing specifications
Sigma-Aldrich
Citric acid, 99%
Sigma-Aldrich
Magnesium chloride hexahydrate, BioReagent, suitable for cell culture, suitable for insect cell culture
Sigma-Aldrich
Sucrose, ≥99.5% (GC), BioXtra
Sigma-Aldrich
Sucrose, ≥99.5% (GC), BioReagent, suitable for cell culture, suitable for insect cell culture
Sigma-Aldrich
Sucrose, ≥99.5% (GC), Grade II, suitable for plant cell culture
Sigma-Aldrich
Citric acid, anhydrous, suitable for cell culture, suitable for plant cell culture
Sigma-Aldrich
Sodium phosphate dibasic, Molecular Biology, ≥98.5% (titration)
Citric acid, anhydrous, European Pharmacopoeia (EP) Reference Standard