METHOD FOR PRODUCING VIRUS-INACTIVATED IMMUNOGLOBULIN SOLUTIONS LOW IN RESIDUAL CAPRYLIC ACID Russian patent published in 2015 - IPC A61K39/395 C07K16/06 

Abstract RU 2561596 C2

FIELD: medicine.

SUBSTANCE: invention refers to a method for producing preparations of blood plasma, namely to a method for purifying immunoglobulin solutions produced by alcohol fractionation from admixtures of caprylic acid applicable at the stage of virus inactivation, and can be used in manufacturing of medicinal biological preparations. The presented method involves processing an immunoglobulin solution in caprylic acid concentrated 6÷100 mM at temperature 15÷37°C and agitating for 0.5÷2 hours. The immunoglobulin solution is processed in caprylic acid at max. ionic force 0.03 M and pH 3.9÷4.6; caprylic acid is removed from the immunoglobulin solution by filtration through a carbon filter at temperature 5÷15°C, max. ionic force 0.03 M and pH 3.9÷4.6; the produced solution contains caprylic acid in an amount of no more than 20 mcg/ml; the aggregate amount makes no more than 1%, the min. immunoglobulin yield is 98%.

EFFECT: invention enables improving the technology of safe virus-inactivated immunoglobulin solutions low in residual caprylic acid and high in end product, maintaining their physical-chemical properties and specific activity, with the use of a simple technique.

3 cl, 4 dwg, 3 tbl, 4 ex

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Authors

Kukunina Tat'Jana Vjacheslavovna

Israfilov Azamat Gabdel'Akhatovich

Zagidullin Nail' Vilenovich

Kornilova Irina Alekseevna

Efimenko Ol'Ga Pavlovna

Shakirova Ehlina Al'Bertovna

Dates

2015-08-27Published

2013-12-18Filed