Abstract：
:Aluminum hydroxide is a critical raw material in the production of many vaccines. It is used as an adjuvant in the formulation of the final bulk vaccine, and for this it must meet the specifications of the European Pharmacopeia Monograph. We investigated whether vaccine stability was affected by the presence of trace amounts of elemental impurities in commercially available aluminum hydroxide. The content of residual elemental impurities in commercially available aluminum hydroxide was determined by selective and sensitive inductively coupled-plasma mass spectrometry and inductively coupled plasma atomic emission spectroscopy. We found significant differences between different suppliers, but also between different lots from the same supplier. Inactivated Japanese encephalitis vaccine, IXIARO(®), was used to study the effect of residual metals in aluminum hydroxide on antigen stability. We propose that antigen degradation occurred via a pathway involving the metal-catalyzed, auto-oxidation of a process-related impurity (sulfite). Thus, sulfite auto-oxidation resulted in antigen degradation when residual Cu was present at elevated concentrations in aluminum hydroxide.
journal_name
Vaccinejournal_title
Vaccineauthors
Schlegl R,Weber M,Wruss J,Low D,Queen K,Stilwell S,Lindblad EB,Möhlen Mdoi
10.1016/j.vaccine.2015.05.103subject
Has Abstractpub_date
2015-11-04 00:00:00pages
5989-96issue
44eissn
0264-410Xissn
1873-2518pii
S0264-410X(15)00788-4journal_volume
33pub_type
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