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Correlated Analytical and Functional Evaluation of Higher Order Structure Perturbations from Oxidation of NISTmAb

January 22, 2023

Author(s)

Tsega Solomon, Frank Delaglio, John Giddens, John Marino, Yihua Bruce Yu, Marc Taraban, Robert Brinson

The clinical efficacy and safety of protein-based drugs such as monoclonal antibodies (mAbs) rely on the integrity of the protein higher order structure (HOS) during product development, manufacturing, storage, and patient administration. As mAb-based

Ligand-bound forced degradation as a strategy to generate functionally relevant analytical challenge materials for assessment of CQAs

April 11, 2022

Author(s)

John Giddens, John E. Schiel

Therapeutic monoclonal antibodies (mAbs) contain a variety of amino acids that are susceptible to enzymatic, chemical, and physical modifications. These modifications can happen throughout production, purification, formulation, and storage and many are

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