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.
Export Options
About this article
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 |
Call for Papers in Thematic Issues
Artificial Intelligence in Bioinformatics
Bioinformatics is an interdisciplinary field that analyzes and explores biological data. This field combines biology and information system. Artificial Intelligence (AI) has attracted great attention as it tries to replicate human intelligence. It has become common technology for analyzing and solving complex data and problems and encompasses sub-fields of machine ...read more
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
Related Articles
-
CARING (CAncer Risk and INsulin analoGues): The Association of Diabetes Mellitus and Cancer Risk with Focus on Possible Determinants - A Systematic Review and a Meta-Analysis
Current Drug Safety JAK Inhibitors: Pharmacology and Clinical Activity in Chronic Myeloprolipherative Neoplasms
Current Medicinal Chemistry Patent Selections:
Recent Patents on Nanotechnology Metabolism of Flavonoids in Human: A Comprehensive Review
Current Drug Metabolism Nutlin-3, A p53-Mdm2 Antagonist for Nasopharyngeal Carcinoma Treatment
Mini-Reviews in Medicinal Chemistry Preclinical and Clinical Studies of Chidamide (CS055/HBI-8000), An Orally Available Subtype-selective HDAC Inhibitor for Cancer Therapy
Anti-Cancer Agents in Medicinal Chemistry Patent Selections:
Recent Patents on Inflammation & Allergy Drug Discovery Promising Activity of Mammalian Target of Rapamycin Inhibitors in Hematologic Malignancies Therapy
Current Signal Transduction Therapy Complement System in SLE as a Target for Antibodies
Current Rheumatology Reviews Pro-apoptotic Activity of BH3-only Proteins and BH3 Mimetics: from Theory to Potential Cancer Therapy
Anti-Cancer Agents in Medicinal Chemistry Recent Advances in the Treatment of Neurogenic Erectile Dysfunction
Recent Patents on CNS Drug Discovery (Discontinued) Strategies for Detecting Genomic DNA Methylation: A Survey of US Patents
Recent Patents on DNA & Gene Sequences Recent Advances in the Treatment of Multiple Myeloma
Current Pharmaceutical Biotechnology Cordycepin in Anticancer Research: Molecular Mechanism of Therapeutic Effects
Current Medicinal Chemistry Osteoprotegerin and Diabetes-Associated Pathologies
Current Molecular Medicine Caveat Receptor: Proteomes on Display
Combinatorial Chemistry & High Throughput Screening Glycosyltransferase and Glypiation Inhibitors
Current Organic Chemistry The Role of Stem Cell Factor and Granulocyte-Colony Stimulating Factor in Treatment of Stroke
Recent Patents on CNS Drug Discovery (Discontinued) Novel Targets and Derived Small Molecule Inhibitors in Multiple Myeloma
Current Cancer Drug Targets Regulatory T Cells: Major Players in the Tumor Microenvironment
Current Pharmaceutical Design