HPLC-RAM-ELSD Analysis of Stabilizers in Monoclonal Antibody (mAb) Formulations

For the structural stabilization of high molecular weight proteins such as monoclonal antibodies (mAbs), the addition of surfactants and stabilizers is necessary. Analyzing surfactants in mAb formulations is not simple, and traditionally, methods such as colorimetry have been used.

They focused on the hydrophilic ODS column Cadenza HS-C18, which can exclude proteins and adsorb low molecular weight compounds, and developed an analytical method for the nonionic surfactant Pluronic F-68 (PF-68) in mAb solutions. They found that similar columns such as Hi SEP and AV-2 had poor separation and reproducibility for PF-68, and only the HS-C18 column provided satisfactory results.

The column demonstrated good LOQ (Limit of Quantitation), linearity, precision, and robustness, concluding that it enables simple and high-sensitivity analysis of mAb formulations.

The Cadenza HS-C18 column plays a crucial role in the analysis of stabilizers in protein formulations.

• Determination of Pluronic F-68 in High Protein Matrices by HPLC-RAM-ELSD(Poster)

  (Courtesy of Helen Chung, Melissa Khor and Jinsu Qiu, Amgen Inc., USA)

Reference:
Direct determination of residual Pluronic F-68 in in-process samples from monoclonal antibody preparations by high performance liquid chromatography
Chung HH, Zhou C, Khor HK, Qiu J.J Chromatogr A., 1218(15), 2106-2113, 2011

• Imtakt Technical Information, TI290E
• Imtakt Technical Information, TI384E

  (Basic information provided by IMTAKT to Amgen)