Journal of Glycobiology
Open Access
ISSN: 2168-958X
+44 1478 350008
ISSN: 2168-958X
+44 1478 350008
Cyrus Agarabi
Centre for Drug Evaluation and Research, U.S. Food and Drug Administration,
Silver Spring, Maryland
United States
Research Article
Automated Microbioreactors and the Characterization of Media Dependent Changes in Antibody Product Glycosylation and Aglycosylation
Author(s): David N. Powers, Sai Rashmika Velugula-Yellela, Nicholas Trunfio, Phillip Angart, Anneliese Faustino and Cyrus AgarabiDavid N. Powers, Sai Rashmika Velugula-Yellela, Nicholas Trunfio, Phillip Angart, Anneliese Faustino and Cyrus Agarabi
The glycosylation state of therapeutic antibodies is a critical quality attribute due to its effect on product efficacy and safety. With the advent of the biosimilar development and the need to match the glycan profile of the originator product, better understanding of how the variables of the bioprocessing procedure control glycosylation is critical. To this effect, we used automated microbioreactors with our in-house model CHO DG 44 cell line and different media types to study differences in antibody outcomes, specifically focusing on N-glycosylation profiles and aglycosylation rates. We observed that different media types resulted in vastly different amounts of high mannose and terminal galactosylation of N-glycans. By measuring the percentage of antibodies that was not N-glycosylated we observed that high mannose outcomes were not correlated to aglycosylation rates. For further an.. View More»
DOI:
10.4172/2168-958X.1000133