There are many possible raw materials in a cell culture media formulation. Although the supply chain for these raw materials remains relatively unchanged over the last 40 years, the way we view the supply chain and the potential for variability on the bioprocesses has changed.
The role of trace elements and their impact on protein and product quality is well documented. As such, trace elements by formulation addition is critical. Variation in these same critical components has been linked to unintended impurities in the prevailing cell culture raw material supply chain. The first step in understanding and managing variability is acquiring reliable data on these critical trace elements.