The market for therapeutic antibodies has been dramatically expanding over the past decades. Antibody drugs exhibit therapeutic effects, such as inhibiting the growth of malignant tumor cells and the activity of immune cells by binding antigens expressed in target cells with high affinity and specificity.
Such antibody drugs are expected to be effective therapeutic agents for unmet medical needs.
Antibody structures are hierarchically formed as primary, secondary, tertiary, and quaternary structures, and it is important to comprehensively evaluate each structure in the characterization of antibodies.
The higher order structures (HOS) formed by therapeutic antibodies determines their efficacy. Because antibodies are unstable macromolecules, their HOS can be affected by various stimuli during the manufacturing process, resulting in reduced drug efficacy and impurities derived from the target substance.
Therefore, HOS is considered to be a Critical Quality Attribute (CQA) and is subject to similarity studies, stability studies, and forced degradation studies in the R&D process from target assessment to lead optimization. In addition, it is monitored during the post-launch manufacturing process.
The JASCO application eBook presents examples of evaluations using various analytical instruments, including Circular Dichroism (CD) spectrometers, Fourier-transform infrared (FTIR) spectrometers, Raman imaging microscopes and High Performance Liquid Chromatography (HPLC).