Lucentis (ranibizumab)

Lucentis (ranibizumab) utilizes the same murine antibody scaffold as (bevacizumab), and is a humanized monoclonal Fab antibody fragment targeted against Vascular Endothelial Growth Factor (VEGF-A).  Lucentis is approved for the treatment of age-related macular degeneration (AMD) – a progressive, age-related deterioration of vision and macular oedema (edema) caused by swelling of the macular region of the retina.

Target Antigen: VEGF

VEGF-A (VEGF) is a mitogen that provides a critical stimulating factor for vascular development. Under normal circumstances, VEGF is required to create new blood vessels during embryonic development or following injury, however over-expression of VEGF is linked to malignant cancers and vascular disease of the retina.  Lucentis’ (ranibizumab) activity is mediated through high affinity binding of the antibody to VEGF, thus preventing the interaction of VEGF with its receptor proteins, and subsequent angiogenic/vasculogenic activity.

Characterization of Ranibizumab Innovator and Biosimilar Products

Investment in our Biosimilar Centre of Excellence coupled with our expertize in assay development allows to deliver a comprehensive biological characterization portfolio for Lucentis (ranibizumab) material. Cutting-edge binding and biological assays provide a platform for thorough characterization and comparability studies for a wide array of distinctive features of VEGF-targeting monoclonal antibody therapies to support the biological evaluation of Lucentis (ranibizumab).

BioOutsource provides end to end support for Lucentis biosimilar manufacture and has extensive experience in the performance of binding and bioassays to support the characterization of both drug substance and drug product, as well as performing extensive comparability studies to support clinical applications. In addition to Lucentis-specific testing methodologies, we provide cell bank manufacturing and biosafety testing to support monoclonal antibodies:

Contact our experts to discuss your Lucentis biosimilar testing needs.

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