Albumin solution and process for the production thereof

Abstract

The invention relates to a therapeutically usable virus-inactivated albumin, and to a process for the preparation of a therapeutically usable virus-inactivated albumin, characterized by the combination of the following steps: (a) subjecting a first aqueous albumin solution to a treatment for virus inactivation by the SD method by contacting it with SD reagents at a temperature of below 45° C.; (b) removing, at least substantially, the SD reagents by oil extraction followed by hydrophobic interaction chromatography, wherein a hydrophobic matrix, especially a matrix to which hydrophobic groups may optionally be bound, is used for said chromatography, with the proviso that said groups are aliphatic groups with more than 24 carbon atoms, to obtain a second albumin solution to which (c) optionally one or more stabilizers selected from the group of sugars, amino acids and sugar alcohols are added, with the proviso that no indole stabilizer and no C6-C10 fatty acid is employed as said stabilizer, whereupon (d) said second albumin solution to which a stabilizer has optionally been added is subjected to final packaging and sterile filtration and optionally filled into final containers.

Dependencies are inferred from the claim text.