Non-clinical in vitro pharmacodynamic studies

Selvita offers broad spectrum of in vitro pharmacodynamic studies used to analyze biosimilar product’s activity in comparison to adequate reference compounds i.e. medicinal products that have already been granted a marketing authorization. Scope of analysis depends on the type of the similar medicinal product and is designed based on clear understanding of its characteristics and activity as well as mechanism of action (MoA). Selvita offers assays that are able to detect even minor changes in biological response to pharmacologically active substances:

 

Binding assays

  • Binding assays based on microscale thermophoresis (MST) measurements

  • Binding assays with several detection modes such as absorbance, fluorescence, fluorescence anisotropy, luminescence, TRF, FRET, etc.,

  • Proximity assays

  • Binding assays based on label-free quantitative analysis of biomolecular interactions in real time using surface plasmon resonance (SPR) technology.

Cell-based functional assays

  • Analysis of receptor autophosphorylation (activation) upon stimulation by biosimilar therapeutics

  • Analysis of phosphorylation of key proteins during the signal transduction

  • Analysis of expression and activation level of pharmacodynamics biomarkers

  • Neutralization assays, complement activation assays

  • Antibody-dependent cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC)

  • Cell metabolism – lipogenesis, lipolysis, glucose uptake, etc,

  • Cell death and differentiation