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
1. Aggregates
2. Trimer
3. Dimer
4. Monomer
| Resolution | ||
|---|---|---|
| monomer/dimer | dimer/trimer | |
| Company B | 2.1 | 2.6 |
| Company A | 2.6 | 2.4 |
| LW-803 | 2.5 | 3.4 |
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.
