Novel identification of mAbs by Raman spectroscopy

Abstract

Abstract The identification of the critical quality attributes (CQAs) of monoclonal antibodies (mAbs) is a key component of quality by design. Traditional detection methods for the identification of mAbs, such as peptide mapping and weak cation‐exchange chromatography (WCX‐HPLC), require sophisticated equipment, experienced staff, and a considerable amount of time. In this study, the novel identification of mAbs was performed using Raman spectroscopy, combined with the evaluation of other CQAs, such as the appearance and purity of size‐exclusion high‐performance liquid chromatography(SEC‐HPLC), charge heterogeneity of WCX‐HPLC, and bioassay. Raman spectroscopy achieved comparable results to the conventional, but complex, approach to identifying anti‐vascular endothelial growth factor antibodies. Raman spectroscopy was used to identify and distinguish between different antibody types. Additionally, the Raman technique with principal component analysis of multivariate algorithms is rapid, efficient, and accurate for mAb identification; this technique has great potential to support biopharmaceutical development and counterfeiters.

Keywords

• appearance
• bioassay
• CEX‐HPLC
• identification
• monoclonal antibody
• PCA