РИСТОЛЬ ДЕБАРТ Пер (ES),ГРАНЧА ГАМОН Сальвадор (ES),ХОРКЕРА НЬЕТО Хуан Игнасио (ES),ФАРО ТОМАС Мария Мерседес (ES),ХОРБА ГРИФОЛЬС Нурия (ES)
申请号：
RU2016138120
公开号：
RU2016138120A
申请日:
2016.09.26
申请国别(地区):
RU
年份:
2018
代理人:
摘要：
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
