FIELD: chemistry.
SUBSTANCE: group of inventions relates to a method of producing an immunoglobulin solution. Method for producing a solution of immunoglobulins from an initial immunoglobulin solution with a degree of purity of not less than 96 %, concentration of 1 to 10 mg/ml, containing 2 to 6 % (w/v) polyethylene glycol (PEG) or polypropylene glycol (PPG), comprises steps a) adding caprylic acid or salts thereof to the initial solution until reaching concentration of 9 to 15 mM; b) bringing pH of solution obtained at step a) to pH 5.0–5.2; c) incubating the solution obtained at step b) for a period of time and at a temperature required to inactivate envelope viruses; and d) performing the step of ultrafiltration/diafiltration of the solution obtained at step c). Also disclosed is the use of caprylic acid for virus inactivation.
EFFECT: group of inventions provides using a lower concentration of caprylate for virus inactivation when producing an immunoglobulin solution, which enables to avoid or does not cause aggregation.
19 cl, 11 tbl, 9 ex
Title | Year | Author | Number |
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VIRUSES INACTIVATION OF WITH APPLICATION OF CAPRYLATE | 2013 |
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METHOD OF PREPARING GAMMA-GLOBULIN SOLUTION DESIGNATED FOR INTRAVENOUS ADMINISTRATION AND PREPARATION PREPARING BY THIS METHOD | 1998 |
|
RU2198668C2 |
METHOD FOR PRODUCING VIRUS-INACTIVATED IMMUNOGLOBULIN SOLUTIONS LOW IN RESIDUAL CAPRYLIC ACID | 2013 |
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Authors
Dates
2019-12-06—Published
2016-09-26—Filed