High molecular weight (HMW) species (or aggregates) are undesirable mAb impurities due to their immunogenic properties.  HMW species are typically removed in the cation exchange step (post Protein A) with varying rates of success.  While gradient elution for HMW species removal in Protein A elution has been reported, its implementation has been limited due to the marginal gains obtained using most commercially available Protein A resins and the processing time and volumes required for pH gradient elution.  The design of a novel Protein A affinity resin from EMD Millipore enables it to remove high levels of HMW species from mAb feed under gradient elution conditions.  Furthermore, pH step elution conditions are explored, which make the process more amenable to scale-up and manufacturing settings.  The broad applicability of the aggregate removal property is demonstrated by data with multiple mAb molecules.  This added benefit of the Protein A resin provides an orthogonal tool in mAb aggregate removal.

Aggregate removal feature of a Protein A resin

247th National Meeting (2014)

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