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Downstream purification process development for therapeutic mAbs is a critical step that must be accomplished under compressed timelines. High-throughput sorbent screening has gained much attention for accelerating process development, based on the rapid acquisition of a large dataset. This study describes the development of a non protein A purification process for a mAb expressed in a CHO cell supernatant. Capture and intermediate steps were screened on three mixed-mode and one cation exchange chromatography sorbents using 200 μL mini-columns compatible with automation. Capacity and yield were evaluated using biolayer interferometry and mAb purity, using SEC-HPLC. A scale-up of the capture and intermediate steps using 2.5 cm id and 0.5 cm id lab-scale columns packed with MEP HyperCel TM mixedmode sorbent and CM Ceramic HyperD R F cation exchange sorbent, respectively, led to an overall mAb recovery yield of 90% and an mAb purity close to 97%. The high-throughput workflow applied here, both in terms of screening and analytics, was a key point to accelerate process development and achieve optimal mAb product purity and yield at minimized time and cost.

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