Modes Of Controlling Charge Variant Distribution In mAb Production By Upstream And Downstream Process Parameters

By Tomas Björkman, Lena Kärf, Anders Ljunglöf, Thomas Falkman, and Anita Vitina

The characteristics of a biological drug, for example, charge variant profile, are determined to a large extent by the upstream expression system and conditions, but can also be influenced by the purification process. Charge variant distribution is a critical quality attribute for MAbs and is therefore of interest to monitor and control during the production process.

In this study, we investigated the effects of cell culture process parameters and medium components on charge variant distribution of a human IgG1 MAb. Furthermore, the MAb charge variant clearance in the downstream chromatography polishing step was evaluated.