PROTEIN STERILISATION BY RADIATION AND ADDITION OF A STABILISING COMPOSITION
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United States of America Patent
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app pub date -
Jun 25, 2009
filing date -
Dec 29, 2006
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Abstract
A method of sterilising a protein, comprises exposing to ionising radiation an at least substantially dry composition comprises a protein and a protective compound or combination of protective compounds having both of the following characteristics: (i) a rate of reaction with singlet oxygen greater than 1×10 7 L mol−1 S−1; (ii) being a reducing agent whilst at the same time containing a proton dissociable group with a pKa no more than 3 units from the pH of the composition. The compound having characteristic (i) is selected from histidine, thiamine and tryptophan, the compound having characteristic (ii) is selected from methionine, malate, citrate, lactate and tiron. The radiation is gamma radiation or electron beam, whereby the preferred dose is 15-40 kGy.
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