FIELD: chemistry.
SUBSTANCE: method comprises the following steps: (a) diafiltration of the partially purified IgG solution to achieve an ethanol concentration of less than 0.5% (w/v); b) stabilization of the solution produced in step a) using sorbitol as a stabilizing agent at a sorbitol concentration of between 30 wt % and 35 wt %; c) heat treatment of the solution produced in step b) at a temperature between 55°C and 63°C for a period of time between 1 and 24 hours; d) selective adsorbtion of aggregates and/or high molecular weight polymers from the solution subjected to the heat treatment in step c) by cation chromatography; and e) diafiltration and preparation of the solution produced in step d).
EFFECT: invention provides stability of the final product.
27 cl, 22 tbl, 18 ex
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Authors
Dates
2017-11-17—Published
2013-03-19—Filed