Chemically defined media is commonly used for therapeutic IgG production in cell culture processes.  These media are formulated with defined chemical components used to prepare the media powders to ensure necessary nutrients are available for the cell culture process.  Janssen has established a raw material characterization program to monitor consistency in powder lots.  During this monitoring, it became apparent that the concentrations of several trace metals showed significant variability and were consistently above the theoretical formulated amounts.  These trace metals are contaminants from other components used in the formulation.  Based on initial screening results, manganese and copper were identified as impurities that warranted investigation due to their potential impact on cell culture.  In this study, we explored the effect of copper and manganese concentrations in basal media on a CHO fed-batch cell culture process in a two factor DOE study using an AMBR250 microbioreactor system.  Copper and manganese concentrations were selected based on historical variability observed in the chemically defined media lots.  This study found copper concentration impacted cell growth and viability and glucose/lactate metabolism, but had minimal impact on product quality, while manganese concentration had less impact on process performance, but had a significant impact on certain product quality attributes.<br/>

Impact of trace metal impurities from chemically defined media on process performance and product quality of an antibody produced in a CHO cell culture process.

2019 Spring National Meeting

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