A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing three-step process. The goal was to separate BsAb monomer from fragments such as the individual heavy and light chain pairs while achieving high purity and yield of BsAb. MabSelect™ PrismA protein A resin was selected for the capture step. Most fragments could be removed as early as the capture step using gradient elution from pH 5 to 3.5, without the need for additional purification steps. BsAb constructs were efficiently purified to give more than 90% purity and 85% yield in the early screening downstream process.
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