As a critical quality attribute of antibodies,acid-base variants are indicative of the heterogeneity level of antibody molecules,batch consistency,and other quality characteristics.They have a significant impact on the efficacy,safety,and stability of antibody drugs.Therefore,it is essential to regulate and control acid-base variants within an acceptable range.For upstream processes,the selection of cell lines with low charge heterogeneity is particularly crucial.Additionally,optimizing culture parameters and fine-tuning medium components can also help reduce the generation of acid-base variants.This paper discusses the reasons for the formation of acid-base variants and regulatory strategies based on upstream processes.
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