Lucentis VEGF Neutralisation Bioassays
BioOutsource offers biological assays that are specifically designed to target the precise function of the therapeutic of interest based on its biomolecular structure and the proposed mechanism of action of the drug compound. Accurate, quantitative and robust biological assays are essential for the in vitro characterisation of Lucentis (ranibizumab) material in order to infer the in vivo efficacy of potential therapeutic compounds.
As Lucentis (ranibizumab) molecules are small, Fab regions of a monoclonal antibody targeting VEGF, their activity can be characterised using a cell line that expresses a reporter construct which emits a signal when VEGF binds to its specific receptor. The addition of Lucentis/ranibizumab neutralises the effect of VEGF in a dose dependent manner and the degree of neutralisation can be quantified by luminescence readout. Sample results are reported as a relative potency measurement against the reference standard material. Characterisation and comparability studies between innovator/originator Lucentis material and ranibizumab biosimilar material have made use of this neutralisation assay to define the VEGF binding neutralisation effect.