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.