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Process Analytics and Intermediate Purification of Bispecific Antibodies with a Non-Affinity Platform

Modern chromatography resins were evaluated for the purification of a bispecific antibody. Hydrophobic CEX and HIC can replace two subsequent affinity chromatography steps for the purification of a κλ-body from the monospecific mAb by-products. The three-step process showed comparable yields to a 3-step affinity platform process currently used to purify a κλ-body. The excellent selectivity of TOYOPEARL MX-Trp-650M and TOYOPEARL Butyl-600M paves the way for future implementation at research, clinical and commercial manufacturing scales. This approach combining reduced cost of goods and higher binding capacities offers an attractive new version of the purification process for the future manufacture of κλ-bodies.

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