The market for biosimilars has grown significantly over the later years since 6 of the top selling mAbs will lose exclusiveness within the next few years. For a biosimilar drug there are a number of attributes that needs to show comparability with the originator drug. Because of its size mAbs are subjected to many different modifications over the production process and these modifications will ultimately result in microheterogeneity. This type of modifications almost exclusively takes place during cell culture and some of this modification may affect mAb charge variant distribution and must be carefully monitored and controlled. However, the occurrence of charge variants are often not fully controllable in the bioreactor and instead needs to be separated in downstream chromatography steps. Separation of charge variants is challenging and requires extremely high selectivity, while often resulting in low yields.<br/>This work presents separation of mAb charge variants in a polishing step. The work includes chromatography resin screening, in which the performance of traditional cation exchange resins and multimodal resins such as Capto™ adhere ImpRes and Capto MMC ImpRes was compared. Process optimization was conducted to achieve efficient removal of unwanted charge variants at reasonable yield. The impact of chromatography resin characteristics (e.g., ligand density and particle size) on charge variant separation will be discussed<br/>

Clearance of mAb charge variant by preparative ion exchange or multimodal chromatography

253rd National Meeting (2017)

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