Analysis of Product Quality of Complex Polymeric IgM Produced by CHO Cells.

Immunoglobulin M (IgM) antibodies are considered as promising biopharmaceutical drugs in the future despite recombinant production is quite challenging as incomplete polymer formation or nucleic acid adherence can decrease the quality of the IgM preparation. Therefore, we defined densitometric and chromatographic methods as suitable tools to analyze the polymer distribution and the remaining nucleic acid content after initial IgM purification. Additionally, the quality of the glycosylation pattern is an important parameter for biological safety and efficacy.