Abatacept is the first in a new class of agents available in Europe for use in patients with an inadequate response to TNF-α antagonists. It is a soluble human fusion protein that selectively modulates T-cell activation without depleting T cells. It was approved by the European Union in May 2007 for the treatment of patients with moderate-to-severe rheumatoid arthritis who have had an inadequate response to, or intolerance of, other disease-modifying anti-rheumatic drugs, including at least one TNF-α antagonist.

Figure 1. Structure of abatacept, a T-cell costimulation modulator. (Östör, A. J. K., 2008)

Abatacept is a fusion protein composed of the Fc region of the immunoglobulin IgG1 fused to the extracellular domain of CTLA-4. In order to activate a T cell and produce an immune response, an antigen presenting cell must present two signals to the T cell. One of those signals is the major histocompatibility complex (MHC), combined with the antigen, and the other signal is the CD80 or CD86 molecule (also known as B7-1 and B7-2). Abatacept binds to the CD80 and CD86 molecule, and prevents the second signal. Without the second signal, the T cell can't be activated. So, this drug is used to treat autoimmune diseases like rheumatoid arthritis, by interfering with the immune activity of T cells for the treatment of rheumatoid arthritis in the case of inadequate response to anti-TNFα therapy.

Abatacept Biosimilars Analysis at Creative Proteomics
To support the analytical development of Abatacept biosimilars or biobetters, Creative Proteomics has set up an analysis program including:

Protein quantification and determination of the extinction coefficient
  • Amino Acid Analysis (AAA), to determine the amino acid composition of a protein without using an external standard.
  • Extinction Coefficient (A280), to calculate protein concentration by measuring UV absorbance at A280. This technique helps demonstrate consistency and comparability between batches.
Characterization of the protein primary structur including
  • Confirming the amino acid sequence
  • Analysis of N- and C-terminal sequence heterogeneity
  • Determination of N- and O-glycosylation sites
  • Quantification of protein modifications
  • Confirming the disulfide bridging
Characterization of the glycosylation pattern
  • N- and O-glycan mapping by mass spectrometry
  • N-andO-gylcan mapping by High Performance Liquid Chromatography (HPLC)
  • Quantification of sialic acid levels
  • Linkage analysis by GC-MS
Characterization of the physicochemical properties
  • Intact protein mass by mass spectrometry
  • Charge isoforms by Isoelectric Focusing (IEF) or Capillary Iso-Electric Focusing (cIEF)
  • Aggregation by AUC or SEC-MALLS

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Creative Proteomics has experienced experts in the field of biosimilars analysis. We are dedicated to serving customers with high-efficiency assays and high-quality data. Creative Proteomics also offers customized services to help you achieve a trouble-free drug developing experience. If you have any questions, please feel free to contact us.

1. Östör, A. J. K. Abatacept: a t-cell co-stimulation modulator for the treatment of rheumatoid arthritis. Clinical Rheumatology, 2008,27(11), 1477-1477.

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