Tocilizumab (TCZ, also known as atlizumab), an immunosuppressive drug, is a humanized monoclonal antibody developed in Japan, mainly for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis (SLE), a severe form of arthritis in children. TCZ was approved as Actemra by European Medicines Agency (EMA) in January 2009 and Food and Drug Administration (FDA) on January 11, 2010.

Interleukin 6 is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer. Autoimmune diseases like RA are associated with abnormally high IL-6 levels. Tocilizumab is directed against lymphoid by binding soluble and membrane bound interleukin-6 receptors and can hinder IL-6 from exerting its pro-inflammatory effects.

Figure1. Immunological targets of tocilizumab (Witte, T, 2015)

Tocilizumab Biosimilar Analysis at Creative Proteomics

At Creative Proteomics, we have long-standing experience to support the development of the TCZ biosimilar. Our experienced scientists and advanced techniques enable us to deliver consistent and high-quality data with cost-efficiency. With our professional platform, Creative Proteomics provides services to characterize TCZ biosimilars in line with ICH Q6B, including but not limited to:

Table1. Tocilizumab biosimilars analysis services at Creative Proteomics

Tocilizumab binding assays
  • Tocilizumab IL-6R Binding Assays
Tocilizumab bioassays
  • Tocilizumab Classical Signaling IL-6R Neutralisation Bioassay
  • Tocilizumab Trans-Signaling IL-6R neutralisation bioassay
Tocilizumab physicochemical analysis
  • Molecular weight and size molecular weight
  • Liquid chromatographic patterns
  • Isoform pattern (ion exchange chromatography)
  • Extinction coefficient, protein concentration analysis
  • Electrophoretic pattern
  • Spectroscopic profiles
Tocilizumab structural analysis
  • Carbohydrate structure
  • Amino acid sequence
  • Amino acid composition
  • Terminal amino acid sequence
  • Peptide mapping
  • Sulfhydryl groups and disulphide bridges

Our Advantages

Creative Proteomics has professional experts to help you design the best strategies for TCZ biosimilars. Moreover, if you have any other needs, we would love to design studies to address your specific requirements. If you have any questions or specific needs, please do not hesitate to contact us.

1. Koike, R; et al. Japan College of Rheumatology 2009 guidelines for the use of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, in rheumatoid arthritis. Mod Rheumatol. 2009, 19:351–357.
2. Witte, T. Methotrexate as combination partner of TNF inhibitors and tocilizumab. What is reasonable from an immunological viewpoint? Clin Rheumatol.2015, 34(4):629-34.

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