Ultrafiltration/Diafiltration (UF/DF) is commonly used in biotech industry to formulate therapeutic proteins into final delivery buffer. UF/DF can be executed using tangential flow filtration (TFF) technology. During this process, the protein of interest interacts with the TFF membrane generating proteinaceous gel layer on the membrane surface that can generate a flux decay decreasing process efficiency.  This problem can become more apparent with proteins that have high tendency to self-aggregate or bind to hydrophobic surfaces. In this study we used such a protein and tested its formulation by UF/DF using arginine or lysine as additives in the diafiltration buffer. The results show decreased flux decay and a shorter processing time when arginine or lysine are present in the diafiltration buffer. Additionally the protein formulated in arginine and lysine show higher solubility and little to no aggregation when compared to the protein in the same buffer without any of these additives.

Use of arginine and lysine as additives in final formulation to increase process performance and product stability

243rd National Meeting (2012)

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