Technical Data: The purification of bispecific antibodies is settled with this! (2)
Selection of chromatography suitable for the separation of aggregated impurities related to antibodies.
During the production of bispecific antibodies (BsAb), various impurities such as mispaired antibodies, aggregates, incomplete antibodies, and fragment antibodies are often generated. Therefore, in the downstream purification process of BsAb, it is important to effectively separate and remove these impurities derived from various products and process-related impurities using chromatography. This report presents the separation modes of chromatography used in the isolation and purification of BsAb that have been previously reported, along with the corresponding packing materials and separation conditions.
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It was found that AEC (TOYOPEARL NH2-750F) effectively removes aggregates and half-antibodies, while HIC (TOYOPEARL Butyl-650M) effectively removes LC missing fragments, deglycosylated antibodies, and host cell proteins (HCP). Additionally, the purity of the purified antibodies was approximately 97% as determined by SE-HPLC.
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The BioScience Division is engaged in business in the "Measurement Field," which includes liquid chromatography, columns, and separation agents, and the "Diagnostics Field," which focuses on immunodiagnostics, glycohemoglobin analysis, and genetic testing. In each field, we are expanding our product lineup based on distinctive technologies and establishing sales bases not only in Japan but also overseas for global business development. Additionally, the BioScience Division consistently handles everything from the development, manufacturing, and sales of equipment and reagents to maintenance and customer support, all managed by the Tosoh Group, including its affiliated companies.