Process to Remove the Size Variants Contained in the Antibody–Chelator Complex PCTA-NCAB001 for Radiolabeling with Copper-64

Understanding the physicochemical properties of antibody–drug conjugates is critical to assess their quality at manufacturing and monitor them during subsequent storage. For radiometal–antibody complexes, it important control antibody–chelator conjugate maintain final product. We have been developing 64Cu-labeled anti-epidermal growth factor receptor antibody NCAB001 (64Cu-NCAB001) for early diagnosis therapy pancreatic cancer with positron-emission tomography. Here, we characterized larger size variants contained in PCTA-NCAB001 by multi-angle light scattering coupled size-exclusion chromatography. Secondly, developed a chromatographic method remove these variants. Lastly, demonstrated stability after removal Dimer oligomers were identified PCTA-NCAB001. These variants, together some smaller could be removed hydrophobic interaction The product, stored 4 °C six months. methods here can applied assure other facilitate development antibody–radiometal tomography radioimmunotherapy malignant cancers.