Antibody drugs have been spotlighted as therapeutic agents which have a high specificity to the target molecule with few side effects. It is known that dimer and/or larger aggregates may be produced during the manufacturing process or storage of antibody drugs. Since it is possible that these aggregates may become immunogenic to induce antibody production and/or cellular immunity in the body and cause side effects, it is important for quality control to analyze these impurities. Monomers and dimers can be separated effectively using PROTEIN LW-803. Therefore, LW-803 is suitable for monitoring impurities.
Sample : 20μL
IgG from recombinant CHO cell 1mg/mL
Columns : Shodex PROTEIN LW-803 (8.0mmI.D. x 300mm) Silica-based SEC column from other manufacturer (7.8mmI.D. x 300mm each) Eluent : 50mM Sodium phosphate buffer (pH7.0) + 0.3M NaCl Flow rate : 1.0mL/min Detector : UV(280nm) Column temp. : Room temp.