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Merck

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
Sorbitol, Pharmaceutical Secondary Standard; Certified Reference Material
Sorbitol, European Pharmacopoeia (EP) Reference Standard
Mannitol, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
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USP
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USP
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USP
Glycine, United States Pharmacopeia (USP) Reference Standard
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myo-Inositol, ≥99% (GC), BioReagent
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Glycine, BioXtra, ≥99% (titration)
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D-Sorbitol, ≥98% (GC)
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D-Sorbitol, ≥98% (GC), Molecular Biology
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myo-Inositol, ≥99%
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Sodium chloride, Molecular Biology, DNase, RNase, and protease, none detected, ≥99% (titration)
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D-Mannitol, ACS reagent
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Sodium chloride, BioXtra, ≥99.5% (AT)
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D-Mannitol, ≥98% (GC)
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Sodium chloride, BioReagent, suitable for cell culture, suitable for insect cell culture, suitable for plant cell culture, ≥99%
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Glycine, ACS reagent, ≥98.5%
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Glycine, 99%, FCC
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Sodium chloride, BioUltra, Molecular Biology, ≥99.5% (AT)
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Glycine, BioUltra, Molecular Biology, ≥99.0% (NT)
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Glycine, ReagentPlus®, ≥99% (HPLC)
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Glycine, suitable for electrophoresis, ≥99%
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Glycine, analytical standard, for nitrogen determination according to Kjeldahl method
Glycine, European Pharmacopoeia (EP) Reference Standard
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Phosphate Standard for IC, TraceCERT®, 1000 mg/L phosphate in water (nominal concentration)
Supelco
Sodium chloride, Pharmaceutical Secondary Standard; Certified Reference Material