| 摘要 |
The invention relates to a therapeutically usable virus-inactivated albumin and a method for producing a therapeutically usable virus- inactivated albumin, which is characterized by a combination of the following steps: (a) a first aqueous albumin solution is subjected to a virus inactivation treatment according to the SD method by contacting said aqueous albumin solution with SD reagents at a temperature of less than 45 °C; (b) the SD reagents are at least essentially removed by means of oil extraction and subsequent hydrophobic interaction chromatography, a hydrophobic matrix, especially a matrix to which optional hydrophobic groups can be bonded, being used for the chromatography process provided that said groups are aliphatic groups wherein C > 24, and a second albumin solution is obtained to which (c) one or several stabilizers from the group comprising sugar, amino acids, and sugar alcohols is/are optionally added provided that no indole stabilizer and no C6- C10 fatty acid are used as stabilizers; whereupon (d) the second albumin solution, to which stabilizer has been optionally added, is finished and sterilized by filtration and optionally filled into final containers.
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