Analytical Techniques for the Characterization and Quantification of Monoclonal Antibodies
Monoclonal antibodies (mAbs) are a fast-growing class of biopharmaceuticals. They are widely used in the identification and detection of cell makers, serum analytes, and pathogenic agents, and are remarkably used for the cure of autoimmune diseases, infectious diseases, or malignancies. The successf...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-02-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/16/2/291 |
| _version_ | 1827755974267502592 |
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| author | Hassan A. Alhazmi Mohammed Albratty |
| author_facet | Hassan A. Alhazmi Mohammed Albratty |
| author_sort | Hassan A. Alhazmi |
| collection | DOAJ |
| description | Monoclonal antibodies (mAbs) are a fast-growing class of biopharmaceuticals. They are widely used in the identification and detection of cell makers, serum analytes, and pathogenic agents, and are remarkably used for the cure of autoimmune diseases, infectious diseases, or malignancies. The successful application of therapeutic mAbs is based on their ability to precisely interact with their appropriate target sites. The precision of mAbs rely on the isolation techniques delivering pure, consistent, stable, and safe lots that can be used for analytical, diagnostic, or therapeutic applications. During the creation of a biologic, the key quality features of a particular mAb, such as structure, post-translational modifications, and activities at the biomolecular and cellular levels, must be characterized and profiled in great detail. This implies the requirement of powerful state of the art analytical techniques for quality control and characterization of mAbs. Until now, various analytical techniques have been developed to characterize and quantify the mAbs according to the regulatory guidelines. The present review summarizes the major techniques used for the analyses of mAbs which include chromatographic, electrophoretic, spectroscopic, and electrochemical methods in addition to the modifications in these methods for improving the quality of mAbs. This compilation of major analytical techniques will help students and researchers to have an overview of the methodologies employed by the biopharmaceutical industry for structural characterization of mAbs for eventual release of therapeutics in the drug market. |
| first_indexed | 2024-03-11T08:17:40Z |
| format | Article |
| id | doaj.art-293709184a4b4e3e8b4e2c59256b8a20 |
| institution | Directory Open Access Journal |
| issn | 1424-8247 |
| language | English |
| last_indexed | 2024-03-11T08:17:40Z |
| publishDate | 2023-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj.art-293709184a4b4e3e8b4e2c59256b8a202023-11-16T22:37:37ZengMDPI AGPharmaceuticals1424-82472023-02-0116229110.3390/ph16020291Analytical Techniques for the Characterization and Quantification of Monoclonal AntibodiesHassan A. Alhazmi0Mohammed Albratty1Department of Pharmaceutical Chemistry and Pharmacognosy, College of Pharmacy, Jazan University, Jazan 45142, Saudi ArabiaDepartment of Pharmaceutical Chemistry and Pharmacognosy, College of Pharmacy, Jazan University, Jazan 45142, Saudi ArabiaMonoclonal antibodies (mAbs) are a fast-growing class of biopharmaceuticals. They are widely used in the identification and detection of cell makers, serum analytes, and pathogenic agents, and are remarkably used for the cure of autoimmune diseases, infectious diseases, or malignancies. The successful application of therapeutic mAbs is based on their ability to precisely interact with their appropriate target sites. The precision of mAbs rely on the isolation techniques delivering pure, consistent, stable, and safe lots that can be used for analytical, diagnostic, or therapeutic applications. During the creation of a biologic, the key quality features of a particular mAb, such as structure, post-translational modifications, and activities at the biomolecular and cellular levels, must be characterized and profiled in great detail. This implies the requirement of powerful state of the art analytical techniques for quality control and characterization of mAbs. Until now, various analytical techniques have been developed to characterize and quantify the mAbs according to the regulatory guidelines. The present review summarizes the major techniques used for the analyses of mAbs which include chromatographic, electrophoretic, spectroscopic, and electrochemical methods in addition to the modifications in these methods for improving the quality of mAbs. This compilation of major analytical techniques will help students and researchers to have an overview of the methodologies employed by the biopharmaceutical industry for structural characterization of mAbs for eventual release of therapeutics in the drug market.https://www.mdpi.com/1424-8247/16/2/291analytical techniqueschromatographicelectrochemicalelectrophoreticmonoclonal antibodiesspectroscopic |
| spellingShingle | Hassan A. Alhazmi Mohammed Albratty Analytical Techniques for the Characterization and Quantification of Monoclonal Antibodies Pharmaceuticals analytical techniques chromatographic electrochemical electrophoretic monoclonal antibodies spectroscopic |
| title | Analytical Techniques for the Characterization and Quantification of Monoclonal Antibodies |
| title_full | Analytical Techniques for the Characterization and Quantification of Monoclonal Antibodies |
| title_fullStr | Analytical Techniques for the Characterization and Quantification of Monoclonal Antibodies |
| title_full_unstemmed | Analytical Techniques for the Characterization and Quantification of Monoclonal Antibodies |
| title_short | Analytical Techniques for the Characterization and Quantification of Monoclonal Antibodies |
| title_sort | analytical techniques for the characterization and quantification of monoclonal antibodies |
| topic | analytical techniques chromatographic electrochemical electrophoretic monoclonal antibodies spectroscopic |
| url | https://www.mdpi.com/1424-8247/16/2/291 |
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