The objective was to purify the antibody fusion protein MP001 from a high product-related HMWs and LMWs containing harvest cell culture fluid. The challenges included low yield of the Protein A capture step and HMWs/LMWs separation from the target protein. After a series of efforts, concentration by UF was implemented before the Protein A step to improve the yield significantly. HMWs/LMWs removal is one of the most important aspects in antibody fusion protein purification. Several Cation Exchange (CEX) and Hydrophobic Interaction Chromatography (HIC) media were evaluated, a novel CEX media Eshnumo CPX, was selected which was able to clear both HMWs impurities and LMWs impurities with gradient elution. After an initial stepwise study approach, the proposed 3-step chromatography steps were combined in streamline run and achieved the target that HMWs and LMWs were less than 2% with yield of 59.7%.

Purification of a fusion protein containing high HMWs and LMWs

249th National Meeting (2015)

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