An Innovative Nano-LC-MS Approach for mAb and ADC Characterization

Oct 24, 2017

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Monoclonal antibodies (mAbs) and antibody­–drug conjugates (ADCs) have emerged as important therapeutics for the treatment of life-threatening diseases like cancer and autoimmune diseases. This has also led to interest in developing biosimilar versions of these therapeutics.  But in contrast to small molecules, exact copies of recombinant mAbs and ADCs cannot be produced due to differences in the cell clone and manufacturing processes used. As a consequence, regulatory agencies evaluate biosimilars based on their level of similarity to, rather than the exact replication of, the originator. In demonstrating similarity, significant pressure is imposed on analytics and both biosimilar and originator need to be characterized and compared in great detail. In addition, from a structural point of view, ADCs possess an unsurpassed complexity since the heterogeneity of the initial antibody is superimposed with the variability associated with the conjugation strategy.

To reveal tiny differences in these complex biological structures, it can be beneficial to use micro-chip based pillar array chromatography columns. In contrast to conventional LC columns that contain randomly packed beads as their stationary phase, micro-chip based pillar array chromatography columns have a separation bed of perfectly ordered and freestanding pillars obtained by lithographic etching of a silicon wafer. The regular mobile phase flow pattern through these micro-chip pillar array columns adds very little dispersion to the overall separation, resulting in better peak resolution, sharper elution peaks and increased sensitivity. The freestanding nature of the pillars also leads to much lower back pressure buildup, and makes it possible to operate longer columns.

In this webcast, Dr. Paul Jacobs of PharmaFluidics will explain the principles and robustness of the micro-chip based pillar array columns. Dr. Koen Sandra of the Research Institute of Chromatography (RIC) will demonstrates how micro pillar array columns, in combination with ultraviolet (UV) spectroscopy and high-resolution mass spectrometry (MS), can be a very powerful tool to assess comparability between originator and biosimilar mAbs and to identify antibody-drug conjugation sites.



Dr. Koen Sandra, Scientific Director, Research Institute of Chromatography

Dr. Paul Jacobs, COO and Co-Founder, PharmaFluidics


Date and Time:

Live: Tuesday, 24 Oct., 2017 | 9 am EDT | 1400 BST | 1500 CEST

After the final airing of the webcast on 24 Oct., 2017 it will be available on demand until 24 Oct., 2018. 

Sponsor: PharmaFluidics

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