Search results for " glycosylation" in Articles / App Notes
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
…s and lysine at the C-terminus of the heavy chain), free sulfhydryl and disulphide bridge structure, glycosylation (in particular the degree of mannosylation, galactosylation, fucosylation, and sialy…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
…roduct variability created by glycoform (micro- and macro-) heterogeneity; difficulty in engineering glycosylation pathways because of cell viability constraints; the inability to completely decouple…
Article
Reimagining Affordable Biosimilars
For example, the glycosylation profile of antibodies made by a single Chinese hamster ovary (CHO) cell line will have several dozen forms of glycan-patterns. Each glycosylated variant of the antibody …
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
When we discuss the sources of variability in cell culture media— it indicates that our customers are making a product and viewing fluctuations in efficacy or glycosylation pattern. It is important to…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
…analyze CQAs and detect impurities that are introduced by deamidation, isomerization, oxidation, and glycosylation, during biopharmaceutical manufacturing. Technology vendors have made improvements t…
Article
Unifying Continuous Biomanufacturing Operations
experiment showed good glycosylation consistency and “minimal variations of the attached glycan species” (2). They added that this so-called “culture and capture” approach is expected to “reduce heter…
Article
Digitalization: The Route to Biopharma 4.0
Glycosylation Flux Analysis Reveals Dynamic Changes of Intracellular Glycosylation Flux Distribution in Chinese Hamster Ovary Fed-Batch Cultures. Metab. Eng. 2017, 43, 9–20. DOI: 10.1016/j.ymben.2017.…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Specifically, what we've seen is trying to control glucose levels to ensure that the protein glycosylation is well behaved. So, the quality is the protein, the critical process parameter you're monito…
Article
Impurity Testing of Biologic Drug Products
Sequence and glycosylation variants are closely related, or even part of the therapeutic protein; therefore, they require highly discriminatory techniques for their quantification. Capillary electroph…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Recently, researchers have proposed a correlation between charge heterogeneity and glycosylation of monoclonal antibody (22).
There are multiple challenges that need to be overcome for perform…