FDA's Francis R.W. Godwin (CDER) and Kathleen Jones, PhD (CBER) detail a record pace of drug warning letters and the CGMP deficiencies most commonly cited in biologics facility inspections.
|Articles|March 3, 2021
Complete Characterization of monoclonal antibodies
Author(s)Thermo Fisher Scientific
Three major workflows for characterizing biopharmaceuticals on a LC-MS platform: intact mass analysis under native and denaturing conditions, subunit analysis complemented with Middle-Down analysis, and peptide mapping.
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