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Novel Identification of mAbs by Raman Spectroscopy
  • +2
  • Maoqin Duan,
  • Jun Liu,
  • and Lan Wang,
  • Jialiang Du,
  • Jialiang Du
Maoqin Duan
National Institutes for Food and Drug Control
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Jun Liu
Thermo Fisher Scientific China Co Ltd
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and Lan Wang
National Institutes for Food and Drug Control

Corresponding Author:[email protected]

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Jialiang Du
National Institutes for Food and Drug Control
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Jialiang Du
National Institutes for Food and Drug Control
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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.
04 Mar 2024Submitted to Engineering Reports
06 Mar 2024Submission Checks Completed
06 Mar 2024Assigned to Editor
06 Mar 2024Review(s) Completed, Editorial Evaluation Pending
11 Mar 2024Reviewer(s) Assigned
13 Apr 2024Editorial Decision: Revise Major
29 May 20241st Revision Received
29 May 2024Submission Checks Completed
29 May 2024Assigned to Editor
30 May 2024Reviewer(s) Assigned
13 Jun 2024Review(s) Completed, Editorial Evaluation Pending