Abstract
The strategy for a comparability assessment is developed on a hierarchical risk-based approach. Critical analysis of physicochemical and biological characterization assays is essential for the development of a good comparability protocol. Therefore, selection and sensitivity of these assays is very important. This article discusses a case study to evaluate the sensitivity of various methods in a comparability assessment of three lots of an IgG1 monoclonal antibody (mAb). Analysis with eighteen methods demonstrated that only six of the methods were sensitive enough to show a measurable difference of comparability under accelerated conditions (40°C). Samples stored at 4°C were found to be comparable by all methods. A brief comparison of the results of biochemical and functional assays with biophysical analysis is discussed. Basic principles, applications, strength, and limitations of different biophysical methods are also discussed here.
Keywords: Comparability, aggregation, degradation, stability, differential scanning calorimetry, fluorescence, light scattering, IgG, monoclonal antibody (mAb), biophysical analysis, physicochemical characterization, in vivo, pharmacokinetic (PK), biophysical techniques, clinical trials.
Current Pharmaceutical Biotechnology
Title:Principles and Applications of Selective Biophysical Methods for Characterization and Comparability Assessment of a Monoclonal Antibody
Volume: 13 Issue: 10
Author(s): Haripada Maity, Yin Lai, Arvind Srivastava and Joel Goldstein
Affiliation:
Keywords: Comparability, aggregation, degradation, stability, differential scanning calorimetry, fluorescence, light scattering, IgG, monoclonal antibody (mAb), biophysical analysis, physicochemical characterization, in vivo, pharmacokinetic (PK), biophysical techniques, clinical trials.
Abstract: The strategy for a comparability assessment is developed on a hierarchical risk-based approach. Critical analysis of physicochemical and biological characterization assays is essential for the development of a good comparability protocol. Therefore, selection and sensitivity of these assays is very important. This article discusses a case study to evaluate the sensitivity of various methods in a comparability assessment of three lots of an IgG1 monoclonal antibody (mAb). Analysis with eighteen methods demonstrated that only six of the methods were sensitive enough to show a measurable difference of comparability under accelerated conditions (40°C). Samples stored at 4°C were found to be comparable by all methods. A brief comparison of the results of biochemical and functional assays with biophysical analysis is discussed. Basic principles, applications, strength, and limitations of different biophysical methods are also discussed here.
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Cite this article as:
Maity Haripada, Lai Yin, Srivastava Arvind and Goldstein Joel, Principles and Applications of Selective Biophysical Methods for Characterization and Comparability Assessment of a Monoclonal Antibody, Current Pharmaceutical Biotechnology 2012; 13 (10) . https://dx.doi.org/10.2174/138920112802273344
DOI https://dx.doi.org/10.2174/138920112802273344 |
Print ISSN 1389-2010 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4316 |
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