To improve the purification of monoclonal antibodies (mAbs) produced by mammalian cell culture, lipid removal by lipase addition was evaluated. A workflow was developed that combined ultra-scale down centrifuge and filtration with design of experiments to screen, solids remaining, lipid concentration and depth filter capacity according to the viability of the cell culture, the enzyme addition and the equivalent flow rate to centrifuge. Results showed a statistically significant impact of lipase treatment on clarification, when CHO cell broth with low viability and high concentration of lipids was exposed to high shear forces. This shows proof of concept of the auto-lipolytic chassis as means to improve manufacturability in mAb processing.
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