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mAbs Volume 14, 2022 - Issue 1
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Physicochemical and biological impact of metal-catalyzed oxidation of IgG1 monoclonal antibodies and antibody-drug conjugates via reactive oxygen species

Zephania Kwong Glovera Pharmaceutical Development, Genentech Inc, South San Francisco, CA, USAView further author information
,
Aaron Weckslerb Analytical Development, Genentech Inc, South San Francisco, CA, USAView further author information
,
Baikuntha Aryalc Laboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USAView further author information
,
Shrenik Mehtaa Pharmaceutical Development, Genentech Inc, South San Francisco, CA, USAView further author information
,
Melissa Peguesc Laboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USAView further author information
,
Wayman Chana Pharmaceutical Development, Genentech Inc, South San Francisco, CA, USAView further author information
,
Mari Lehtimakic Laboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USAView further author information
,
Allen Luod Biological Technologies, Genentech Inc, South San Francisco, CA, USAView further author information
,
Alavattam Sreedharaa Pharmaceutical Development, Genentech Inc, South San Francisco, CA, USACorrespondence[email protected]
View further author information
&
V. Ashutosh Raoc Laboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USACorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0001-6817-8049View further author information
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Article: 2122957 | Received 09 Jun 2022, Accepted 02 Sep 2022, Published online: 24 Sep 2022

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Tsega L. Solomon, Frank Delaglio, John P. Giddens, John P. Marino, Yihua Bruce Yu, Marc B. Taraban & Robert G. Brinson. (2023) Correlated analytical and functional evaluation of higher order structure perturbations from oxidation of NISTmAb. mAbs 15:1.
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Articles from other publishers (8)

Tongdan Wang, Zi-Ao Huang, Moyin Zhou, Ruxin Wang, Yufei Li, Longyun Guo, Xiaolin Cao & Jincui Huang. (2024) Drug deconjugation-assisted peptide mapping by LC–MS/MS to identify conjugation sites and quantify site occupancy for antibody-drug conjugates. Journal of Pharmaceutical and Biomedical Analysis 243, pages 116098.
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Paulina Fischer, Olivia M. Merkel, Michael Siedler & Martin Huelsmeyer. (2024) Development of a high throughput oxidation profiling strategy for monoclonal antibody products. European Journal of Pharmaceutics and Biopharmaceutics 199, pages 114301.
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Shravan Sreenivasan & Anurag S. Rathore. (2024) Taurine, a Naturally Occurring Amino Acid, as a Physical Stability Enhancer of Different Monoclonal Antibodies. The AAPS Journal 26:1.
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Hao Lou, Yilue Zhang, Krzysztof Kuczera, Michael J. Hageman & Christian Schöneich. (2023) Molecular Dynamics Simulation of an Iron(III) Binding Site on the Fc Domain of IgG1 Relevant for Visible Light-Induced Protein Fragmentation. Molecular Pharmaceutics 21:2, pages 501-512.
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Shravan Sreenivasan & Anurag S. Rathore. (2023) Combined Presence of Ferrous Ions and Hydrogen Peroxide in Normal Saline and In Vitro Models Induces Enhanced Aggregation of Therapeutic IgG due to Hydroxyl Radicals. Molecular Pharmaceutics 20:6, pages 3033-3048.
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Emily Holz, Martine Darwish, Devin B. Tesar & Whitney Shatz-Binder. (2023) A Review of Protein- and Peptide-Based Chemical Conjugates: Past, Present, and Future. Pharmaceutics 15:2, pages 600.
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Stefano Colombo, Alicia Alonso, Rebeca Real, Roshan Goswami, Maria Carmen Suarez, Samuel Ogueta, Margarida Almeida, Laxmi Adhikary, Mónica G. Malmierca & Ivan S. de Melo. (2023) Improvement of monoclonal antibody stability by modulating trace metal iron concentration in cell culture media: A case study. Process Biochemistry 125, pages 130-140.
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Yilue Zhang & Christian Schöneich. (2022) Visible Light Induces Site-Specific Oxidative Heavy Chain Fragmentation of a Monoclonal Antibody (IgG1) Mediated by an Iron(III)-Containing Histidine Buffer. Molecular Pharmaceutics 20:1, pages 650-662.
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