Protein sterilisation by radiation and addition of a...

A - Human Necessities – 61 – L

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A61L 2/00 (2006.01) A61L 2/08 (2006.01)

Patent

CA 2673819

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 x 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.

Procédé de stérilisation d'une protéine, lequel consiste à exposer à un rayonnement ionisant une composition au moins sensiblement sèche comprenant une protéine et un composé protecteur ou une association de composés protecteurs ayant les deux caractéristiques suivantes : (i) une vitesse de réaction avec l'oxygène singulet supérieure à 1 x 107 L.mol-1.s-1; (ii) le fait d'être un agent réducteur tout en contenant en même temps un groupe dissociable de ses protons ayant un pKa qui n'est pas différent de plus de 3 unités du pH de la composition. Le composé ayant la caractéristique (i) est sélectionné parmi l'histidine, la thiamine et le tryptophane, le composé ayant la caractéristique (ii) est sélectionné parmi la méthionine, un malate, un citrate, un lactate et le tiron (acide 4,5-dihydroxy-1,3-benzènedisulfonique). Le rayonnement est un rayonnement gamma ou un faisceau d'électrons, la dose préférée étant de 15-40 kGy.

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