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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
[Quality Evaluation of Therapeutic Antibodies by Multi-attribute Method]
Noritaka Hashii1, Michiko Tajiri1, Akiko Ishii-Watabe1
1Division of Biological Chemistry and Biologicals, National Institute of Health Sciences.
Therapeutic monoclonal antibody (mAb) structural analysis is complex. The multi-attribute method (MAM) using LC/MS offers a new quantitative approach for monitoring mAb modifications, improving quality control over traditional methods.
Area of Science:
- Biochemistry
- Analytical Chemistry
- Pharmaceutical Sciences
Background:
- Therapeutic monoclonal antibodies (mAbs) require rigorous characterization due to structural heterogeneity impacting safety and efficacy.
- Rapid and comprehensive structural analysis of complex mAbs remains a significant challenge in biopharmaceutical development.
Purpose of the Study:
- To review typical mAb structural heterogeneities and the principles of the multi-attribute method (MAM).
- To present an optimized sample preparation method for MAM.
- To demonstrate the simultaneous monitoring of multiple mAb modifications using MAM.
Main Methods:
- Utilizing peptide mapping coupled with liquid chromatography-mass spectrometry (LC/MS) for structural analysis.
- Implementing the multi-attribute method (MAM) as a quantitative quality control technique.
- Developing and optimizing sample preparation protocols for enhanced MAM performance.
Main Results:
- MAM enables simultaneous quantitative monitoring of multiple mAb modifications, unlike traditional identification-focused peptide mapping.
- Demonstrated successful application of MAM for analyzing deamidation, oxidation, N-terminal pyroglutamination, C-terminal clipping, and glycosylation.
- An optimized sample preparation method was introduced for improved MAM efficiency.
Conclusions:
- MAM represents a powerful, quantitative alternative to conventional chromatographic methods for therapeutic mAb quality control.
- The presented MAM approach facilitates comprehensive characterization of mAb structural heterogeneity.
- This method supports the development and safe manufacturing of therapeutic mAbs.
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