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Merck
CN

G005458

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

application for HPLC

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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

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.

Legal Information

TSKgel is a registered trademark of Tosoh Corporation

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