Development of quantitative analysis methods of Rituximab and it's biosimilar in biological samples

Author: Liping HOU ¹ ; Yuyang YAN ¹ ; Li LI ¹ ; Dongsheng OUYANG ¹ ; Liping HOU ² ; Yuyang YAN ² ; Li LI ² ; Jianbo YANG ² ; Dongsheng OUYANG ² ; Jianbo YANG ³ ; Jianbo YANG ⁴ ; Dongsheng OUYANG ⁵
Author Information

1. Changsha DUXACT Co., Ltd.
2. Hunan Key Laboratory for Bioanalysis of Complex Matrix Samples
3. Department of Laboratory Medicine and Pathology, Medical School, University of Minnesota
4. Department of Otolaryngology, Medical School, University of Minnesota
5. Department of Clinical Pharmacology, Xiangya Hospital, Central South University
Publication Type:Journal Article
Keywords: Biosimilar; Immunogenicity; LBA; LC-MS/MS; Rituximab
From: Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(1):98-104
CountryChina
Language:Chinese
Abstract: Rituximab is the main monoclonal antibody for targeted therapy currently. With more rituximab biosimilars appearing and clinical evaluation need increasing, it is crucial to develop rapid and effective quantitative methods to determine the rituximab blood concentration in biological matrices for drug metabolism and pharmacokinetics (DMPK) analysis. This article reviewed the application of ligand binding method (LBA), liquid chromatography-tandem mass spectrometry (LC-MS/MS) and emerging quantitative technology to detect the blood concentration of Rituximab, which may provide valuable information for the analysts and testers when developing quantitative methods for rituximab and its biosimilars.