Herceptin (trastuzumab)

Herceptin is one of the most well-known of all monoclonal antibodies used to treat cancer. Herceptin (trastuzumab) is a humanised monoclonal antibody that binds to the extracellular component of the Her2/neu receptor, a 185-kDa transmembrane oncoprotein that is over expressed in approximately 20 to 25% of breast cancer patients.

Target Antigen: HER2

Herceptin (trastuzumab) functions with a variety of different of mechanisms, but the main action is to bind to the extracellular membrane portion of the Human Epidermal growth factor Receptor 2 (HER-2) on the surface of cancer cells, preventing the activation of its intra cellular tyrosine kinase. The HER-2 receptor receives “growth” signals from external sources and moves the cells into a growth phase. Due to the over expression of HER-2 in breast cancer cells (upwards of 2 log increase over non-cancer breast cells) the signals are amplified resulting in rapidly growing cancers.

Characterization of Trastuzumab Innovator and Biosimilar Products

Herceptin (trastuzumab) has been designed as a human Fc-Gamma-1 isotype. The Fab-related function of Herceptin (trastuzumab) allows binding with high affinity to the extracellular domain of the HER2/neu receptor causing inhibition of cell proliferation and prevention of angiogenesis. In addition, Herceptin acts on the immune system by mediating Antibody Dependant Cellular Cytotoxicity (ADCC) and can fix complement, but is considered unable to mediate Complement Dependant Cell Cytotoxicity (CDC). Another mechanism which might be associated with the antitumor effect of Herceptin is the ability of the antibody to prevent dimerisation of the HER-2 receptors with other members of the HER family; dimerisation induces pro-angiogenic factors such as Vascular Endothelial Growth Factor (VEGF) which assist in tumour development.

BioOutsource offers a comprehensive range of integrated services to support the biological, physicochemical and structural evaluation of Herceptin including characterization and comparability. Our off-the-shelf binding assays and bioassays include affinity measurements for Her2 and the Fc-Receptors, C1q binding as well as the Herceptin-mediated inhibition of proliferation assay, Complement Dependent Cytotoxicity assay (CDC assay) and Antibody Dependent Cellular Cytotoxicity assay (ADCC assay). In addition, BioOutsource also offer a range of platform methods to assess physicochemical properties and structural attributes of Herceptin innovators and biosimilars. All services have been designed to support both Phase I and Phase III applications.

BioOutsource also provides the following generic testing and development services for monoclonal antibodies:

Contact our experts to discuss your Herceptin biosimilar testing needs.

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