The Different Colors of mAbs in Solution

Abstract

The color of a therapeutic monoclonal antibody solution is a critical quality attribute. Consistency of color is typically assessed at time of release and during stability studies against preset criteria for late stage clinical and commercial products. A therapeutic protein solution’s color may be determined by visual inspection or by more quantitative methods as per the different geographical area compendia. The nature and intensity of the color of a therapeutic protein solution is typically determined relative to calibrated standards. This review covers the analytical methodologies used for determining the color of a protein solution and presents an overview of protein variants and impurities known to contribute to colored recombinant therapeutic protein solutions.

Keywords

• monoclonal antibody
• color testing
• United States Pharmacopeia USP<631>, USP<1061>
• European Pharmacopoeia EP2.2.2
• tristimulus colorimetry
• tryptophan oxidation