FIELD: biochemistry.
SUBSTANCE: invention relates to biochemistry. Group of inventions is described, which involves method of producing human immunoglobulin and preparation of human immunoglobulin, obtained using said method. Method includes stage of dissolving of Cohn component I+II+III or Cohn component II+III in water for injections; deposition with caprylic acid or caprylate; first stage of anion-exchange chromatography, involving bringing pH of filtrate obtained at step (2), to 5.2, cleaning by anion-exchange chromatography and obtaining eluating solution; deposition of IgM, including control of conductivity of eluating solution obtained at step (3), up to 500–1,000 µS/cm by means of water and further bringing pH to 6.0–7.3,with subsequent settling for 1–2 hours, filtration and filtrate collection; second stage of anion-exchange chromatography, involving bringing pH of filtrate obtained at step (4) to 5.6, subsequent purification by anion-exchange chromatography and collection of eluating solution; production of human immunoglobulin by dialysis of eluating solution obtained at step (5), by ultrafiltration, obtaining pharmaceutical form and inactivation of viruses.
EFFECT: invention extends range of methods for producing human immunoglobulin.
9 cl, 2 dwg, 3 tbl, 2 ex
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Authors
Dates
2017-03-22—Published
2013-02-22—Filed