title: 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.
authors.affiliation: Leukocare AG München, Am Klopferspitz 19, Martinsried, Germany. martin.scholz@leukocare.com
authors.forename: Martin
authors.initials: M
authors.lastname: Scholz
authors.forename: Angelika
authors.initials: A
authors.lastname: Lüking
mesh_terms: D000906:Antibodies / Q000737:chemistry* / Q000378:metabolism; D001709:Biotechnology / Q000379:methods*; D006801:Humans; D046228:Microarray Analysis / Q000295:instrumentation / Q000379:methods*; D011485:Protein Binding; D055550:Protein Stability; D011506:Proteins / Q000737:chemistry* / Q000378:metabolism
chemical_list: D000906:Antibodies; D011506:Proteins