A protein-stabilizing technology for enhanced antibody stability and antibody-binding profiles in a microchip array

Abstract

The stability of therapeutic antibodies during downstream processing and storage is important for functionality and quality. To determine functional antibody performance, the UNIchip® high-density protein microarray with 384 recombinant antigenic targets was developed; this allows characterization of antibody specificity by generating standardized quantitative binding profiles. In this study, we used UNIchip® to test the efficacy of a novel protein stabilizing and protecting solution (SPS) to preserve the binding specificity and binding strength of a therapeutic anti-TNF-α antibody (Adalimumab; Humira). Our results show that reconstituted SPS-formulated and lyophilized Adalimumab elicits significantly less off-target activity after reconstitution and preserves binding strength even after six weeks of storage at 40°C compared with Adalimumab that underwent the same treatment with the original formulation. By means of UNIchip® , we were able to confirm the protein stabilizing effects of SPS as shown by preserved antibody functionality.