Abatacept (Orencia®) is is a soluble and homodimeric fusion protein for anti-TNF alpha treatment in Rheumatoid Arthritis.

It consists of the Fc part of an IgG1 antibody linked via a disulphide bond to the extracellular domain of the protein receptor CTLA4 that is found on activated T-cell surfaces. It is produced in a CHO cell line.

Abatacept binds a so called B7 protein on antigen presenting cells thereby blocking the necessary co-signal to a T-cell. The T-cells cannot be activated and, therefore, T lymphocyte activation is prevented.

The protein structure includes N- and O-glycosylation and leads to different glyco- and isoforms by additional N- and C-terminal heterogeneity. Due to the complexity of the protein, such a detailed analysis of the primary structure as well as the glycosylation can only be achieved by a combination of mass spectrometry, bioinformatics, HPLC and electrophoretic methods.

To support the analytical development of Abatacept biosimilars or biobetters, PPS has set up an analysis program in accordance with ICH Q6B guidelines, including method setup, validation of customer-specific methods, and release testing. This package includes:

    • 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
    • N- and O-glycan mapping by mass spectromtry
    • N- and O-gylcan mapping by 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 IEF, cIEF or IEX
    • Aggregation by AUC or SEC-MALLS

The specific bioassays are performed by a strategic partner:

  • T-cell proliferation inhibition (Mixed Lymphocyte Reaction)

 

Your contact for Abatacept at Protagen Protein Services GmbH

Martin-Blueggel 150x100px

Martin Blüggel

Chief Executive Officer (CEO)
Our business development team will be happy to assist you with your project.

Phone: +49 (0) 231 9742-6100
Email: salesproteinservices@ProtagenProteinServices.com