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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
Sodium chloride, Pharmaceutical Secondary Standard; Certified Reference Material
Mannitol, European Pharmacopoeia (EP) Reference Standard
Sorbitol, European Pharmacopoeia (EP) Reference Standard
USP
Sorbitol, United States Pharmacopeia (USP) Reference Standard
Glycine, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Lithium chloride, anhydrous, free-flowing, Redi-Dri, ReagentPlus®, 99%
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Sigma-Aldrich
D-Mannitol, ACS reagent
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D-Mannitol, meets EP, FCC, USP testing specifications
Sigma-Aldrich
D-Mannitol, BioXtra, ≥98% (HPLC)
Sigma-Aldrich
D-Mannitol, ≥98% (GC), suitable for plant cell culture
Sigma-Aldrich
Sodium chloride, BioReagent, suitable for cell culture, suitable for insect cell culture, suitable for plant cell culture, ≥99%
Sigma-Aldrich
D-Mannitol, ≥98% (GC)
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Sodium chloride, for molecular biology, DNase, RNase, and protease, none detected, ≥99% (titration)
Sigma-Aldrich
Sodium chloride, tablet
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Sodium chloride, BioXtra, ≥99.5% (AT)
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Glycine, BioXtra, ≥99% (titration)
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Glycine, from non-animal source, meets EP, JP, USP testing specifications, suitable for cell culture, ≥98.5%
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D-Sorbitol, ≥98% (GC), for molecular biology
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myo-Inositol, ≥99% (GC), BioReagent
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myo-Inositol, ≥99%
SAFC
Glycine
Sigma-Aldrich
D-Sorbitol, ≥98% (GC), BioReagent, suitable for cell culture, suitable for plant cell culture
Sigma-Aldrich
Sodium chloride solution, 5 M
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D-Sorbitol, ≥98% (GC), BioXtra
Sigma-Aldrich
Glycine, BioUltra, for molecular biology, ≥99.0% (NT)
Sigma-Aldrich
Glycine, tested according to Ph. Eur.
Sigma-Aldrich
Glycine, puriss. p.a., reag. Ph. Eur., buffer substance, 99.7-101% (calc. to the dried substance)
Sigma-Aldrich
D-Mannitol, BioUltra, ≥99.0% (sum of enantiomers, HPLC)
Supelco
Lithium chloride solution, 1 M in ethanol