Process for obtaining an IgG composition through heat treatment
Inventors
Ristol Debart, Pere • Grancha Gamon, Salvador
Assignees
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Publication Number
US-9200032-B2
Publication Date
2015-12-01
Expiration Date
Abstract
A process for obtaining an IgG composition involves heat treatment. This process obtains an IgG composition from an IgG solution partly purified from human plasma, in which by applying intermediate heat treatment and without using reagents to precipitate high molecular weight aggregates/polymers and/or proteins virtually total elimination of the IgG polymers generated during the process is achieved. Furthermore this process offers high productivity, lower production costs and is easy to implement in comparison with the processes of the know art. In addition to this, by using this process stability is imparted to the final product in liquid.
Core Innovation
The invention relates to a process for obtaining a liquid IgG composition from an IgG solution partly purified from human plasma. The process includes diafiltering the partly purified IgG solution, stabilising the resulting solution, and heat treating the stabilised solution such that no more than 3% high molecular weight aggregates and polymers are generated.
The process then includes selectively adsorbing at least 85% of the high molecular weight aggregates and polymers by cation exchange chromatography, followed by diafiltering again to obtain the liquid IgG composition. The resulting liquid IgG composition is stable for at least 1 year at a temperature of 2–30°C and a pH of 4.6–5.8.
The document emphasises stabilization and defined process steps to enable long-term liquid stability under specified conditions. The overall workflow is characterised by intermediate heat treatment together with cation exchange chromatography to control and remove high molecular weight aggregates and polymers.
Claims Coverage
The partial content provides one independent claim defining the main process for producing a liquid IgG composition with controlled aggregate/polymer formation and selective removal, followed by final diafiltration to achieve long-term stability.
Liquid IgG from partly purified human plasma IgG solution via diafiltration, stabilization, controlled heat treatment, cation exchange removal, and final diafiltration
A process for obtaining a liquid IgG composition from an IgG solution partly purified from human plasma, comprising diafiltering, stabilising, heat treating such that no more than 3% high molecular weigh aggregates and polymers are generated, selectively adsorbing at least 85% of the high molecular weight aggregates and polymers in the heat-treated solution by cation exchange chromatography, and diafiltering again to obtain the liquid IgG composition.
Long-term stability of the liquid IgG composition at defined temperature and pH
The liquid IgG composition obtained is stable for at least 1 year at a temperature of 2–30°C and a pH of 4.6–5.8.
Selective removal of high molecular weight aggregates and polymers by cation exchange chromatography
The process selectively adsorbs at least 85% of the high molecular weight aggregates and polymers by cation exchange chromatography in the step after heat treating.
Limiting generation of high molecular weight aggregates and polymers during heat treatment
The process heat treating step is carried out whereby no more than 3% high molecular weigh aggregates and polymers are generated.
Across the independent claim, the main inventive features are controlling heat treatment to limit high molecular weight aggregate/polymer generation to no more than 3%, removing at least 85% of those aggregates/polymers by cation exchange chromatography, and producing a liquid IgG composition that is stable for at least 1 year at 2–30°C and pH 4.6–5.8.
Stated Advantages
Produces a liquid IgG composition stable for at least 1 year at a temperature of 2–30°C and a pH of 4.6–5.8.
Heat treating whereby no more than 3% high molecular weigh aggregates and polymers are generated.
Selectively adsorbing at least 85% of high molecular weight aggregates and polymers by cation exchange chromatography.
Documented Applications
Manufacturing/obtaining a liquid IgG composition from an IgG solution partly purified from human plasma.
Optional inclusion of at least one viral inactivation/elimination treatment step within the process.
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