The Effect of Cell Culture Medium Components on the Color of Monoclonal Antibody Substance
As Subcutaneous injection of biotherapeutic drugs has become a valuable alternative to intravenous administration in many disease areas,and high drug concentrations are increasingly becoming the norm for monoclonal antibodies.As concentrations of monoclonal antibody increase,drug substance may show a more intense color than at lower concentrations,and the biopharmaceutical industry has recently reported atypical drug substance colors other than colorless or yellowish.As an important quality index for the study of release,stability and comparability of biologics,it is necessary to identify the root cause of drug substance discoloration and reduce its color,which also simplifies the design process of placebos for clinical research.Relevant studies have shown that drug substance color is caused by some specific components in the medium.This paper summarizes the effects of different medium components on drug substance color of monoclonal antibody.Iron ions lead to the oxidation of tryptophan in protein to formylkynurenine and kynurenine products,which may be the reason for the yellow color of drug substance;The pink color of drug substance is caused by residual vitamin B12 that binds to drug substance;Brown is a combination of yellow and pink.
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