Understanding Trace Element Variability In Custom Cell Culture Media

Trace elements are included in cell culture media formulations as they are known to be important for cell culture performance. At desired concentrations, they can positively impact cellular growth and biotherapeutic efficacy, as well as protein quality attributes like glycosylation. However, if trace elements are introduced as impurities through incoming raw materials, concentrations can drift outside of acceptable ranges, which may indicate a need for tighter control to improve media consistency.

In this project, Thermo Fisher Scientific worked with a multinational biopharmaceutical company to investigate trace element variability in its custom cell culture media. Within a year, using a risk-based, collaborative approach, both teams were able to thoroughly characterize incoming specific raw materials and implement proactive measures for reducing the risk of impurities, ultimately providing the company with a long-term risk mitigation strategy.