Antibody (mAb)- based drugs and their drugs and their biosimilars have attracted attention in recent years and are being developed as therapeutics for various diseases including cancer. Recent studies have indicated that clinical outcomes vary among patients treated with antibody therapeutics and produce various side effects, such as vascular disorders. Several analytical methods for the characterization of mAb therapeutics have been descried, such as liquid chromatography- mass spectrometry (LC-MS), circular dichroism spectrometry (CD), Differential scanning calorimetry (DSC), Dynamic light scattering (DLS). This protein heterogeneity results from sequence variations generated from proteolysis or transcriptional/translational errors, from post-translational modifications (PTMs), and degradation of products which are formed during processing or final product storage. For this reason, a detailed characterization and sensitive analytical techniques are necessary to assure the safety, quality and efficacy of therapeutic protein products. Mass spectrometry (MS) is widely used within structural and functional proteomics for a variety of tasks including protein quality assessment, identification, and characterization.

However, the cutting-edge protein characterization method can serve as a technical barrier, the method must be validated based on regulations. This study was performed to validate standard operating procedure (SOP) method for improve analytical techniques of 2 types of mAb therapeutics by LC-MS based analytical method based on ICH guideline.