In rheumatoid arthritis and some other inflammatory conditions, tumor necrosis factor (TNF, tumor necrosis factor alpha, TNF-α) is produced in the body, causing inflammation, pain, and damage to the bones and joints. Anti-TNF drugs such as Etanercept block the action of TNF-α and decrease its role in disorders involving excess inflammation in humans and other animals, including autoimmune diseases such as ankylosing spondylitis, juvenile rheumatoid arthritis, psoriasis arthritis, rheumatoid arthritis, and potentially, in a variety of other disorders mediated by excess TNF-α.

Figure 1. The 3D structure of TNF alpha (Reed, C.; et al. 1997)

Etanercept (Enbrel; Amgen, Inc, Thousand Oaks, Calif) is a recombinant human protein that is the first Food and Drug Administration (FDA) approved treatment for psoriatic arthritis. It has the potential to treat autoimmune diseases caused by an overactive immune response by inhibiting TNF-α, which is the “master regulator” of the inflammatory (immune) response in many organ systems. Etanercept, 934 amino acids long, is a homodimer consisting of two chains of 75kDa each and binds to TNF-α. The protein structure is complicated by the high degree of N- and O-glycosylation. In addition, an N- and C-terminal sequence heterogeneity adds to the complexity of the protein analysis.

Etanercept Biosimilar analysis at Creative Proteomics

At Creative Proteomics, we have long-standing experience in the analysis of different variants of Etanercept originators, biosimilars and biobetters. Due to the complexity of the protein, such a detailed analysis of the primary structure, as well as the glycosylation can be achieved by a combination of mass spectrometry, bioinformatics, high-performance liquid chromatography (HPLC) and electrophoretic methods. To support the development of Etanercept biosimilars or biobetters, Creative Proteomics has set up an analysis program in accordance with ICB Q6B guidelines, including method setup, validation of customer-specific methods, and release testing.

With our professional platform, we can provide various information about Etanercept, which can combine with our expertise in the field of protein structure-function to help you find solutions to problems along the product development, including:
➤ Characterization of the protein primary structure

➤ Characterization of the glycosylation pattern

➤ Characterization of the physicochemical properties

Our Advantages

We have extensive experience in the analysis of different variants of Etanercept originators, biosimilars and biobetters. Based on professional knowledge and experienced staff, Creative Proteomics provides a wide range of information about Etanercept. Our ordering procedure is as follows. If you have any questions or specific needs, do not hesitate to contact us.

1. Goffe, Ben.; et al. Etanercept; An overview. Journal of the American Academy of Dermatology. 2003; 49:105-111.
2. Reed, C.; et al. Crystal structure of TNF-alpha mutant R31D with greater affinity for receptor R1 compared with R2. Protein Eng. 1997; 10:1101-7.

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