Protein A chromatography continues to be the main capture step in the industrial purification of monoclonal antibodies and Fc-fusion proteins. Due to the relatively high cost of these adsorbents, a long resin lifetime is critical to the overall process economics. In some processes, the performance of Protein A resins throughout their lifetime is reduced as a result of fouling, due to accumulation of product or impurities, or as a consequence of the degradation of the Protein A ligand through hydrolysis or denaturation. Although these issues are less common with alkali-tolerant adsorbents, a reduction in capacity over time can still occur as a function of concentration and time of exposure to sodium hydroxide solutions commonly used for cleaning. In this work, we used a polymeric-based alkali-tolerant resin to assess the effectiveness of various excipients added to sodium hydroxide solutions to mitigate the ligand degradation that results from the contact with NaOH alone. In addition, various cleaning solutions were tested for their ability to clean columns that were intentionally fouled. The output of this work could be leveraged to enhance the performance of Protein A resins throughout their lifetime and as a result reduce processing costs.

Evaluation of excipients and cleaning solutions to enhance the performance of Protein A media

251st National Meeting (2016)

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