A commercial rituximab drug (anti-CD20 monoclonal antibody) was analyzed using an aqueous SEC (GFC) column, PROTEIN LW-803. In addition to the mAb peak, there were oligomer (aggregate) and fragment peaks that were considered to be the decomposition product of mAb. Moreover, by using two columns in series, a fragment which have retention time very close to the monomer was detected. The LW-803 has an improved separation ability in the molecular weight range of IgG, thus it provides superior analytical capability for the quality control of antibody production to monitor not only the high-molecular weight impurities, aggregates, but also fragmentation.
*Between aggregates and monomer, use of one column generally provides a sufficient separation, however between fragment and monomer, use of two columns in series may provide a superior separation.
Sample : 20 µL
Column : Shodex PROTEIN LW-803 (8.0 mm I.D. x 300 mm) Eluent : 50 mM Sodium phosphate buffer (pH7.0) + 0.3 M NaCl Flow rate : 1.0 mL/min Detector : UV (280 nm) Column temp. : 25 °C
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