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Etanercept is a recombinant Fc-fusion protein widely used to treat rheumatic diseases. This protein is highly glycosylated and contains numerous O- and N-glycosylation sites. Since glycosylation is recognized as an important critical quality attribute (CQA) that can affect immunogenicity, solubility, and stability of Fc-fusion proteins, it should be thoroughly characterized. In this work, hydrophilic interaction chromatography (HILIC) was combined with high resolution mass spectrometry (HRMS) by using a QTOF/MS instrument to assess glycosylation of etanercept at the middle-up level of analysis (fragments of circa 25-30 kDa). In addition, a combination of different enzymatic digestion procedures (i.e. glycosidase, sialidase and protease) was systematically employed to facilitate spectra deconvolution. With the developed procedure, the main post-translational modifications (PTMs) of etanercept were assessed, and a global overview of the subunit-specific distribution of the glycosylation pattern was obtained at a middle-up level of analysis.
This article was published in the following journal.
Name: Analytical chemistry
Glycosylation of monoclonal antibodies (mAbs) is a critical quality attribute that can impact mAb drug efficacy and safety. The mAb glycans are inherently heterogeneous in chemical structure and compo...
For a long time, glycoprotein production has been limited by the inherent properties of production hosts. Glycosylation of biopharmaceuticals has been regarded as a necessary evil, often needed for pr...
Background After the expiry of the patent of reference etanercept, several biosimilars have been developed, including SB4. Objective To study safety and efficacy of SB4 in psoriatic patients previousl...
Function study and application of an intact glycoprotein requires structural characterization of both the protein backbone and the glycan moiety; the former has been successfully demonstrated with sel...
Etanercept is a recombinant fusion protein of TNFR2 with the Fc portion of human IgG1. Etanercept, an anti-TNF drug, treats autoimmune diseases and improves patients' health. The main goal of the pres...
This is a research study whose purpose is to test the effectiveness of etanercept (Enbrel) in the treatment of moderate to severe lichen planus. No studies have been done on the effective...
This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg o...
The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in subjects with psoriatic arthritis. To do this, eta...
RATIONALE: New diagnostic procedures, such as glycan analysis, may be effective in finding ovarian epithelial cancer. PURPOSE: This clinical trial is studying how well glycan analysis wor...
The purpose of this study is to evaluate the efficacy of adding methotrexate to etanercept compared with etanercept monotherapy as measured by the proportion of subjects achieving a 75% im...
The presence of apparently similar characters for which the genetic evidence indicates that different genes or different genetic mechanisms are involved in different pedigrees. In clinical settings genetic heterogeneity refers to the presence of a variety of genetic defects which cause the same disease, often due to mutations at different loci on the same gene, a finding common to many human diseases including ALZHEIMER DISEASE; CYSTIC FIBROSIS; LIPOPROTEIN LIPASE DEFICIENCY, FAMILIAL; and POLYCYSTIC KIDNEY DISEASES. (Rieger, et al., Glossary of Genetics: Classical and Molecular, 5th ed; Segen, Dictionary of Modern Medicine, 1992)
A mass of KERATIN-producing squamous EPITHELIUM that resembles an inverted (suck-in) bag of skin in the MIDDLE EAR. It arises from the eardrum (TYMPANIC MEMBRANE) and grows into the MIDDLE EAR causing erosion of EAR OSSICLES and MASTOID that contains the INNER EAR.
That middle portion of the hypothalamus containing the arcuate, dorsomedial, and ventromedial nuclei, and the tuber cinereum. The pituitary gland can also be considered part of the middle hypothalamic region.
The genetic constitution of the individual; the characterization of the genes.
The passive movement of molecules exceeding the rate expected by simple diffusion. No energy is expended in the process. It is achieved by the introduction of passively diffusing molecules to an enviroment or path that is more favorable to the movement of those molecules. Examples of facilitated diffusion are passive transport of hydrophilic substances across a lipid membrane through hydrophilic pores that traverse the membrane, and the sliding of a DNA BINDING PROTEIN along a strand of DNA.
Recombinant DNA is the formation of a novel DNA sequence by the formation of two DNA strands. These are taken from two different organisms. These recombinant DNA molecules can be made with recombinant DNA technology. The procedure is to cut the DNA of ...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...