Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control-Reference-Cited by-同舟云学术

Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control

Published:2023-04-14 Issue:1 Volume:15 Page:
ISSN:1942-0862
Container-title:mAbs
language:en
Short-container-title:mAbs

Author:

Yang Feng¹,Zhang Jennifer¹,Buettner Alexander²,Vosika Eva²,Sadek Monica¹,Hao Zhiqi¹,Reusch Dietmar²,Koenig Maximiliane³,Chan Wayman¹,Bathke Anja⁴,Pallat Hilary⁵,Lundin Victor¹,Kepert Jochen Felix²,Bulau Patrick⁴,Deperalta Galahad¹,Yu Christopher¹,Beardsley Richard¹,Camilli Tura⁶,Harris Reed¹,Stults John¹

Affiliation:

1. Pharma Technical Development, Genentech, A member of the Roche Group, South San Francisco, CA, USA

2. Pharma Technical Development Analytics, Roche Diagnostics GmbH, Penzberg, Germany

3. Large Molecule Research, Roche Pharma Research and Early Development, Roche Innovation Center Munich, Penzberg, Germany

4. Pharma Technical Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland

5. Pharma Quality & Compliance–Analytical Science, Genentech, A member of the Roche Group, South San Francisco, CA, USA

6. Pharma Technical Regulatory, Genentech, A Member of the Roche Group, South San Francisco, CA, USA

Funder

no funding associated with the work featured

Publisher

Informa UK Limited

Subject

Immunology,Immunology and Allergy

Link

https://www.tandfonline.com/doi/pdf/10.1080/19420862.2023.2197668

Reference66 articles.

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2. Implementation of a High-Resolution Liquid Chromatography–Mass Spectrometry Method in Quality Control Laboratories for Release and Stability Testing of a Commercial Antibody Product

3. Application of a Quantitative LC–MS Multiattribute Method for Monitoring Site-Specific Glycan Heterogeneity on a Monoclonal Antibody Containing Two N-Linked Glycosylation Sites

4. Simultaneous monitoring of oxidation, deamidation, isomerization, and glycosylation of monoclonal antibodies by liquid chromatography-mass spectrometry method with ultrafast tryptic digestion

5. A Quadrupole Dalton-based multi-attribute method for product characterization, process development, and quality control of therapeutic proteins

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