G005458

HPLC Analysis of mAb Charge Variants on TSKgel^® CM-STAT

application for HPLC

Properties

• technique(s): HPLC: suitable
• test parameters: column: TSKgel CM-STAT, 10 cm x 4.6 mm I.D., 7 μm particles (821966); mobile phase: [A] 20 mM MES buffer, pH 6.0; [B] 0.5 M NaCl in buffer A, pH 6.0; gradient: 0% B (0 min), 30% B (15 min), 100% B (15 min),; ; 0% B (17 min), 10% B (17 min), 10% B (21 min); flow rate: 1 mL/min; column temp.: ambient; detector: UV, 280 nm; injection: 20 μL; sample: monoclonal antibodies (mAb A through E)
• suitability: application for HPLC
• application(s): life science and biopharma

Description

Analysis Note

A TSKgel CM-STAT weak cation exchange (WCX) column was applied to separate charge variants of several monoclonal antibodies. The typical analysis time on conventional 25 cm long WCX columns of about eighty minutes could be significantly reduced when separation was performed on a 10 cm TSKgel CM-STAT column, filled with 7 μm particles. The analysis profiles for five antibodies show that high resolution analysis can be obtained in about 20 minutes analysis time.

Citation

From "Ion Exchange Chromatography for the Characterization of Biotherapeutics" in The Supelco Reporter, Vol. 29.3, page 20.

Legal Information

TSKgel is a registered trademark of Tosoh Corporation