The downstream purification of bispecific antibodies

Bispecific antibodies, a class of therapeutic antibodies, can simultaneously bind to two distinct targets. Compared with monospecific antibodies, bispecific antibodies offer advantages, including superior efficacy and reduced side effects. However, because of their structural complexity, the purification of bispecific antibodies is highly challenging. The purification process must strike a delicate balance between purity and productivity, eliminating a broad spectrum of contaminants, including product-related and process-related impurities, while also maximizing the yield wherever feasible. This review systematically describes the strategies for bispecific antibody capture, the elimination of product-related impurities, and the mitigation of the formation of process-related impurities, thereby, providing guidance for the development of downstream purification processes for bispecific antibodies.