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Biopharmaceutical

Conclusion References
1. Physicochemical Stability of Monoclonal Antibodies: A Review,
Journal of Pharmaceutical Sciences, Volume­190, Issue­1,
・ Complete peptide mapping and PTMs analysis workflow for
169­190,2020.
control and stress induced mAb samples is described.
2. Rapid assessment of oxidation via middle­down LCMS correlates with
・ Sequence coverage of more than 92% was obtained for both
methionine side­chain solvent­accessible surface area for 121 clinical
heavy and light chain of the mAb even with single enzyme stage monoclonal antibodies, Mabs, Volume 9 (4), 646­653, 2017.
digestion.
3. Data­Dependent Analysis Approach in LC/HRMS: Annotation of
・ Excellent mass accuracy with good stability, comprehensive Natural Product Components, 04­JMST­208­EN.
fragmentation pattern and sensitivity offered by LCMS-9030
4. Monoclonal Antibody Workflows on the Shimadzu Q­TOF LCMS­
helps in reliable and in-depth characterization of mAb and also 9030 Using the Protein Metrics Software Suite, SSI­LCMS­103.
has helped in identification of sites susceptible to oxidation and
5. Structural Elucidation of Post­Translational Modifications in
deamidation modifications. Such studies can help in deep under- Monoclonal Antibodies, ACS Symposium Series, ISBN13:
standing of Critical Quality Attributes (CQA) of the product and 9780841230293, Chapter 3, Volume 1201, 119­183, 2015.
to further develop Multiple-Attribute Method (MAM).

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