Stable aqueous systems comprising proteins

C - Chemistry – Metallurgy – 12 – N

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C12N 9/96 (2006.01) A61K 39/39 (2006.01)

Patent

CA 2614006

An aqueous system comprises a protein and one or more stabilising agents, characterised in that (i) the one or more stabilising agents have ionisable groups capable of exchanging protons with the protein and with the ionised products of water dissociation; (ii) the ionisable groups include first groups that are positively charged when protonated and uncharged when deprotonated, and second groups that are uncharged when protonated and negatively charged when deprotonated; and (v) the pH of the composition is within a range of protein stability that is at least 50% of the maximum stability of the protein with respect to pH.

L'invention concerne un système aqueux comprenant une protéine et un ou plusieurs agents stabilisants, caractérisé en ce que (i) ledit un ou plusieurs agents stabilisants comportent des groupes ionisables capables d'échanger des protons avec la protéine et avec les produits ionisés de la dissociation de l'eau ; (ii) les groupes ionisables incluent des premiers groupes chargés positivement lorsqu'ils sont protonés et non chargés lorsqu'ils sont déprotonés, et des seconds groupes non chargés lorsqu'ils sont protonés et chargés négativement lorsqu'ils sont déprotonés ; et (iii) le pH de la composition est compris dans une gamme de stabilité de la protéine étant d'au moins 50 % de la stabilité maximale de la protéine vis à vis du pH.

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