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Manufacture Bioprocessing - Upstream & Downstream, Process Control, Analytical Science


sponsored by Nibrt

October 23 2019 | 3pm BST

Presenter: Dr Roisin O’Flaherty

A report on the first large-scale comparison of glycoanalytical techniques for mAb characterization in industry and academia.

The production of monoclonal antibodies as biologic drugs has expanded dramatically. Associated with this trend has been a sudden increase in the number of laboratories determining a critical and heterogeneous property of these drugs, namely their glycosylation. This, in turn, has led to a proliferation of analysis methods, including high performance liquid chromatography (HPLC), capillary electrophoresis (CE) and mass spectrometry (MS)-based. The comparability of variety of these methods, especially as they vary lab-to-lab, presents a major challenge in understanding the meaning and accuracy of these measurements. Consequently, a large interlaboratory study was conducted by NIST to determine measurement variability in identifying and quantifying N-glycans of a NIST reference material, NISTmAb, across laboratories from 73 laboratories worldwide. The results will be presented.

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