FIELD: pharmacology.
SUBSTANCE: method for blood plasma albumin preparation for pharmaceutical use includes the following steps: (i) obtaining an eluate of fraction IV-1 or a Cohen F fraction; (ii) adjustment of the albumin solution concentration to a value of less than 5 wt %; (iii) solution pH adjustment to a pH of 5 or less; (iv) caprylic acid (octanoic acid) or sodium caprylate addition to a concentration of 20 mM; (v) solution temperature increasing to 27-30°C; (vi) solution incubation for 30-120 minutes, followed by solution filtration; ultrafiltration and diafiltration; solution volume composition and increasing; sterilisation, containers filling and albumin pasteurization. A method for viruses inactivation in an albumin-containing solution comprises the following steps: (i) adjustment of albumin solution concentration to a value of less than 5 wt %; (ii) solution pH adjustment to a pH of 5 or less; (iii) caprylic acid (octanoic acid) or sodium caprylate addition; (iv) solution temperature increasing to 27-30°C and (v) solution incubation for 30-120 minutes.
EFFECT: reduced risk of blood-borne viruses transmission, reduced time of albumin purification.
16 cl, 7 dwg, 4 tbl, 4 ex
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Authors
Dates
2017-10-11—Published
2013-07-24—Filed