mAbs (Dec 2023)
Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control
- Feng Yang,
- Jennifer Zhang,
- Alexander Buettner,
- Eva Vosika,
- Monica Sadek,
- Zhiqi Hao,
- Dietmar Reusch,
- Maximiliane Koenig,
- Wayman Chan,
- Anja Bathke,
- Hilary Pallat,
- Victor Lundin,
- Jochen Felix Kepert,
- Patrick Bulau,
- Galahad Deperalta,
- Christopher Yu,
- Richard Beardsley,
- Tura Camilli,
- Reed Harris,
- John Stults
Affiliations
- Feng Yang
- Pharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA
- Jennifer Zhang
- Pharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA
- Alexander Buettner
- Pharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, Germany
- Eva Vosika
- Pharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, Germany
- Monica Sadek
- Pharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA
- Zhiqi Hao
- Pharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA
- Dietmar Reusch
- Pharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, Germany
- Maximiliane Koenig
- Large Molecule Research, Roche Pharma Research and Early Development, Roche Innovation Center Munich, Penzberg, Germany
- Wayman Chan
- Pharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA
- Anja Bathke
- Pharma Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland
- Hilary Pallat
- Pharma Quality & Compliance–Analytical Science, Genentech, A member of the Roche Group, South San Francisco, CA, USA
- Victor Lundin
- Pharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA
- Jochen Felix Kepert
- Pharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, Germany
- Patrick Bulau
- Pharma Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland
- Galahad Deperalta
- Pharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA
- Christopher Yu
- Pharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA
- Richard Beardsley
- Pharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA
- Tura Camilli
- Pharma Technical Regulatory, Genentech, A Member of the Roche Group, South San Francisco, CA, USA
- Reed Harris
- Pharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA
- John Stults
- Pharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA
- DOI
- https://doi.org/10.1080/19420862.2023.2197668
- Journal volume & issue
-
Vol. 15,
no. 1
Abstract
ABSTRACTThe multi-attribute method (MAM), a liquid chromatography-mass spectrometry (LC-MS)-based peptide mapping method, has gained increased interest and applications in the biopharmaceutical industry. MAM can, in one method, provide targeted quantitation of multiple site-specific product quality attributes, as well as new peak detection. In this review, we focus on the scientific and regulatory considerations of using MAM in product quality attribute monitoring and quality control (QC) of therapeutic proteins. We highlight MAM implementation challenges and solutions with several case studies, and provide our perspective on the opportunities to use MS in QC for applications other than standard peptide mapping-based MAM.
Keywords
- product quality attribute
- quality control
- LC-MS
- multi-attribute method
- Intact MAM
- targeted attribute quantitation
