Buffer system for protein purification

摘要

The invention is directed to a method for producing a polypeptide composition comprising: combining a polypeptide with a volatile additive to form a liquid mixture and lyophilizing the liquid mixture to obtain a lyophilized polypeptide composition.

主权项

1. A chromatography system consisting essentially of:
i. a sodium chloride-free multi-component buffer system for the purification of a recombinant protein, and ii. a series of chromatography steps, wherein the chromatography steps comprise affinity chromatography and one or more additional chromatography steps chosen from: anion exchange chromatography, cation exchange chromatography, and mixed-mode chromatography, wherein the chromatography steps are operated in a mode chosen from: bind-elute mode and flow-through mode, wherein the sodium chloride-free multi-component buffer system consists essentially of: (a) an organic acid, (b) an organic base, and (c) at least one component chosen from an alkaline metal and an ammonium salt of the conjugate base of the organic acid of (a); and wherein the sodium chloride-free multi-component buffer system is used throughout the series of chromatography steps.