Global intercompany assessment of ICIEF platform comparability for the characterization of therapeutic proteins
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DOI: 10.1002/elps.202100348
Abstract: An international team spanning 19 sites across 18 biopharmaceutical and in vitro diagnostics companies in the United States, Europe, and China, along with one regulatory agency, was formed to compare the precision and robustness of… read more here.
Keywords: nist mab; comparability; ice3 maurice; icief ... See more keywords
Characterization of therapeutic mAb charge heterogeneity by iCIEF coupled to mass spectrometry (iCIEF–MS)
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DOI: 10.1002/elps.202200170
Abstract: Imaged capillary isoelectric focusing (iCIEF) has emerged as an important technique for therapeutic monoclonal antibody (mAb) charge heterogeneity analysis in the biopharmaceutical context, providing imaged detection and quantitation by UV without a mobilization step. Besides… read more here.
Keywords: charge; icief; charge heterogeneity; mab charge ... See more keywords
Imaged capillary isoelectric focusing (icIEF) tandem high resolution mass spectrometry for charged heterogeneity of protein drugs in biopharmaceutical discovery.
Sign Up to like & getrecommendations! Published in 2022 at "Journal of pharmaceutical and biomedical analysis"
DOI: 10.2139/ssrn.4213342
Abstract: Since the first commercial imaged capillary isoelectric focusing (icIEF) instrument was developed twenty years ago, the technology has become the gold standard of quality and manufacturing process control in the biopharmaceutical industry. This is owing… read more here.
Keywords: mass spectrometry; isoelectric focusing; high resolution; icief ... See more keywords