METHOD OF VIRUS INACTIVATION FOR IMMUNOGLOBULIN PRODUCTION Russian patent published in 2009 - IPC A61K39/395 C07K16/06 

FIELD: medicine.

SUBSTANCE: invention refers to virus inactivation in production of immunoglobulins, particularly of G fraction. The method virus inactivation for production of G fraction immunoglobulin includes purification of dissolved immunoglobulin recovered by Kohn's spirit fractionation. Purified dissolved immunoglobulin is prepared with a solvent detergent mixture which is acetate buffer solution 0.05 M at pH 5.5, containing 1 wt % tri-n-butylphosphate and 1 wt % polysorbate 80. Preparation represents stirring of the mixture within 12-16 hours followed with dilution with acetate buffer solution 0.05 M at pH 5.5 containing 1 wt % sodium octanoate, sodium chloride 0.15 M and propylene glycol concentrated 0.2 g/l. Prepared immunoglobulin is immobilised on sulphoprolylcation sorbent with grain size 50 mcm and sorption capacity 55 mg/cm³, and two-stage washed by column chromatography followed with elution. The first stage of washing implies acetate buffer solution 0.05 M at pH 5.5 containing 1 wt % sodium octanoate, sodium chloride 0.15 M and propylene glycol concentrated 0.2 g/l. The second stage of washing applies acetate buffer solution 0.05 M at pH 5.5. At the first stage the product is washed with volume related to 5 volumes of sorbent, while at the second stage washing is performed with volume related to three volumes of sorbent.

EFFECT: invention provides high-effective virus inactivation that improves viral safety of immunoglobulin preparations.

3 cl, 7 ex