Search results for " glycans"
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
On a therapeutic protein, the composition of these glycans can significantly impact the drug’s stability, pharmacokinetics, and biological activity. Thus, glycan structure is a critical quality attrib…
Article
N-Glycan Analysis of Biotherapeutic Proteins
N-Glycosylation, where glycans are attached to the nitrogen side chain of asparagine, is perhaps the most well understood form of glycosylation in biotherapeutics, particularly on mAbs, in which the N…
Article
Analysis of Glycosylation in Biosimilars
Nonetheless the glycans must be characterized in order to understand the functioning of the molecule, assess the outcome of the manufacturing process, and fulfill the requirements of the International…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
…es to understand the quantities of the different types of monosaccharides present, the nature of the glycans in terms of their antennary profile, and linkage of monosaccharides in each structure but …
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
The composition of glycans at the Fc site (see Figure 10A) was essentially unchanged over 22 days, with percentages of G0F, G1F, and G2F (biantennary glycans with 0, 1, or 2 galactoses) holding steady…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
…etics, and pharmacodynamics of TGPs are presented in Figure 1:
• Presence of high-mannose glycans, in particular, the five-mannose glycan (Man5), reduces the serum half-life of antibodies (7). Ma…
Article
Antibody Production in Microbial Hosts
Still, the use of this strain in antibody bioprocessing suffers from disadvantages, such as the occasional addition of heterogeneous O-linked glycans and slight differences in the N-glycan structure. …
Article
Elucidating Biosimilars Characterization
Characterization of the glycosylation present on recombinant proteins is particularly important as the glycans attached to the molecule can modulate the stability and ability of the molecule to elicit…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The addition of sucrose has been known to result in higher levels of high mannose glycans. Glucose (< 0.70 mM) concentrations resulted in decreased sialylation and increased presence of minor glycan s…
Article
Ensuring the Quality of Biologicals
May 02, 2015
By Stephen Wicks, PhD
Pharmaceutical Technology
Volume 39, Issue 5
The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …