Manufacturing & Analytical Characterization
Lorena Lopez, BSc / MBA
LC Applications Scientist
Agilent Technologies
Boston, Massachusetts
Description: In the modern biopharmaceutical industry, active pharmaceutical ingredients (APIs) such as monoclonal antibodies (mAbs) are produced from genetically modified living cells kept in nutrition media. These media contain amino acids, vitamins, minerals, and sugars. Typically, an essential amino acid such as glutamine is present in large excess as a source of external nitrogen for the living cells. The content of this essential amino acid must be monitored quantitatively. If the essential amino acid is consumed by the cells in the bioreactor, more amino acid must be added to maintain a level necessary to keep the cells alive. The concentration of the amino acid can be determined by their derivatization, making them measurable by UV or fluorescent detection after a chromatographic separation1. In this experiment, the concentration of Glutamine was observed in the presence of Dulbeccos Modified Eagle Medium (DMEM) formulation from a simulated bioreactor over the course of 2 days. The Infinity II Online Sample Manager fully automated the sampling handling from, reactor sampling to dilution and precolumn derivatization while monitoring controls the to complete experiment in an unattended, safe, and economic method.