Immunoglobulin fusion protein formulations

A - Human Necessities – 61 – K

Patent

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Details

A61K 39/395 (2006.01)

Patent

CA 2630115

The present invention provides compositions of Ig fusion proteins, especially compositions including an Ig fusion protein, a bulking agent, a disaccharide, a surfactant, and a buffer. In one aspect, these compositions are stable under long-term storage or at least one freeze/thaw cycle. The invention also provides methods of preparation of the Ig fusion protein compositions. In one aspect, compositions of the invention are lyophilized. In a further aspect, the compositions are lyophilized by a process that includes an annealing step.

La présente invention se rapporte à des compositions à base de protéines hybrides d'Ig, en particulier à des compositions contenant une protéine hybride d'Ig, un agent gonflant, un disaccharide, un tensioactif et un tampon. Dans un aspect, les compositions selon l'invention présentent une bonne stabilité au stockage de longue durée ou à moins un cycle de congélation-décongélation. L'invention a également trait à des procédés de préparation desdites compositions de protéines hybrides d'Ig. Dans un autre aspect, lesdites compositions sont lyophilisées par un processus comportant une étape de recuit.

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