Orthogonal Assessment of Biotherapeutic Glycosylation: A Case Study Correlating N-Glycan Core Afucosylation of Herceptin with Mechanism of Action-Reference-Cited by-同舟云学术

Orthogonal Assessment of Biotherapeutic Glycosylation: A Case Study Correlating N-Glycan Core Afucosylation of Herceptin with Mechanism of Action

Published:2016-09-26 Issue:20 Volume:88 Page:10259-10265
ISSN:0003-2700
Container-title:Analytical Chemistry
language:en
Short-container-title:Anal. Chem.

Author:

Upton Rosie¹,Bell Leonard²,Guy Colin²,Caldwell Paul²,Estdale Sian²,Barran Perdita E.¹,Firth David²

Affiliation:

1. Manchester Institute of Biotechnology, Michael Barber Centre for Collaborative Mass Spectrometry, University of Manchester, 131 Princess Street, Manchester, M1 7DN, United Kingdom

2. Covance Laboratories Ltd., Otley Road, Harrogate, HG3 1PY, United Kingdom

Funder

Biotechnology and Biological Sciences Research Council

Publisher

American Chemical Society (ACS)

Subject

Analytical Chemistry

Link

http://pubs.acs.org/doi/pdf/10.1021/acs.analchem.6b02994

Reference44 articles.

1. Quality by design for biopharmaceuticals

2. U.S. Food and Drug Adminstration. http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf, 2015.

3. Towards the implementation of quality by design to the production of therapeutic monoclonal antibodies with desired glycosylation patterns

4. Characterizing biological products and assessing comparability following manufacturing changes

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