Developability Profiling

Successful translation of a therapeutic antibody candidate to the clinic depends on its physicochemical properties. Antibody degradation or instability for example, can have a great impact on its biological function. IPA streamlines in silico and in vitro processes with high-throughput workflows for developability profiling, by assessing critical antibody quality attributes.

IPA’s in silico developability profiling toolset includes sequence analysis, Fv model-based structure analysis, and Fv model-based surface analysis for antibody lead candidates to identify e.g. chemical liability motifs, aggregation prone regions, and charge properties. These in silico engineering approaches facilitate focused antibody de-risking, if required, to improve the mAb developability profile.

In vitro analytical tools allow for the study of various critical quality attributes like production yield, target- and/or poly-reactivity, colloidal stability, melting temperature, self- and/or cross-interaction, solubility, and fragmentation.

IPA is equipped with a state-of-the-art bio-inert HPLC enabling analytical determination of mAb biochemical and biophysical properties such as aggregation levels (SEC-HPLC), colloidal stability (SMAC-HPLC), cross interaction (CIC-HPLC), Asn deamidation and isomerization (CIEX-HPLC), and Met/Trp oxidation (HIC-HPLC).