Mapping and Identification of Biopharmaceutical Grade Cell Culture Media by MEKC

Abstract

This paper describes a rapid micellar electrokinetic capillary chromatographic (MEKC) method for the mapping and identification of biopharmaceutical grade cell culture media. The method has been validated and we currently use it as an identity test for raw material release testing of cell culture media. The MEKC method is capable of resolving components of cell culture medium with specificity, matching the sample profile with the expected component profile, and precision. The precision of the assay was shown by comparison of peak migration times and relative peak areas of three injections of test media on each of three days. The intra-day and inter-day peak migration times and UV214 nm responses (% total peaks areas) of the assay were within acceptable ranges. The intermediate precision (% Relative Standard Deviation) of peak migration times was less than 3%. The intermediate precision (% Relative Standard Deviation) of relative percent peak areas was less than 10% for major peaks present. A linear relationship between response (% total peaks areas) and the concentration of the cell culture medium was observed, with the average correlation coefficient of >0.96 for major peaks (each accounting for greater than 2% of total peaks areas). Based on the identification by chromatographic profile, linearity, and precision, the MEKC method for the mapping of cell culture media components is suitable for the intended use.