The color of monoclonal antibody drug substance and/or product is a product quality attribute that needs to be controlled. This presentation will focus on cell culture media and process conditions that impact drug substance color. The concentrations of B vitamins, iron, and hydrocortisone, the substitution of cystine for cysteine, and culture temperature had significant effects on color. Potential mechanisms that could explain these effects will be discussed. Based on the proposed mechanism for coloration, novel media additives for reducing antibody coloration were screened in in vitro and cell culture studies. Cell culture data with these media additives, that have the potential to reduce antibody coloration without impacting culture productivity, will be presented. The described changes to the cell culture process had some unexpected effects on the charge variant profile. Cell culture strategies for mitigating the impact on charge variant profile will also be described.

Understanding the impact of cell culture media components and process conditions on drug substance color

245th National Meeting (2013)

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