Valentina D'Atri

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Pushing Boundries

Valentina D'Atri;Jelle De Vos

December 1st 2023

An introduction from our guest editors.

Reed Harris retired in 2022 after a 39-year career in biotechnology, starting as a research assistant and finishing as a senior staff scientist in the Roche-Genentech Pharma Technical Development department, with strategic, review, and teaching responsibilities. His former roles includ: Head of Investigational Medicinal Product Quality for Roche, senior director of Analytical Development & QC, analytical characterization scientist for Herceptin and Xolair, and head of a protein structure lab. He was the global (Genentech + Novartis) Xolair technical development team leader from Phase 2 through licensing. Reed is a CASSS Distinguished Fellow and has been an author of 49 publications, including 14 as corresponding author. He was a leader in the development of Roche-Genentech’s strategies for post-approval comparability exercises, clinical and commercial specifications, the identification of critical quality attributes, linking structure to function, the use of a risk-based Quality by Design approach for control strategy development, unexpected protein modification identification, and curiosity-based thinking.

Critical Thinking On Characterization

Valentina D'Atri;Jelle De Vos

December 1st 2023

An interview with Reed Harris on critical quality attributes and other contemporary trends in biopharm analysis.

Hydrophilic Interaction Chromatography for the Characterization of Therapeutic Monoclonal Antibodies at Protein, Peptide, and Glycan Levels

Isabel Vandenheede;Koen Sandra;Emmie Dumont;Valentina D'Atri;Davy Guillarme;Pat Sandra

August 1st 2017

These are exciting times to be involved in monoclonal antibody (mAb) and biopharmaceutical analysis. Advances in instrumentation, column technology, and reagents are providing analysts with a new set of tools to broaden their understanding of the highly complex products they are studying. A good example is hydrophilic interaction chromatography (HILIC). While the technique has been used for more than 20 years to profile enzymatically released and fluorescently labelled N-glycans, the introduction of new columns (sub-2-µm and widepore) has paved the way to explore the technique further. Remarkable separations at all levels of analysis, including protein, peptide, and glycan levels, have been demonstrated. With data from the authors’ laboratories, the versatility of HILIC in mAb analysis will be demonstrated in this month’s “Biopharmaceutical Perspectives”.