Abstract

Industrial application of impurity flocculation to streamline antibody purification processes

Author(s): Michael Felo, Yun Kenneth Kang*, James Hamzik, Paul Balderes and Dale L Ludwig

Flocculation technologies offer significant benefits to industrial mammalian cell culture processes, including increased clarification efficiency, impurity removal and process simplification. In this paper, the application and performance of flocculation technologies employed in the harvest process of monoclonal antibody Chinese hamster ovary cell culture are reviewed. Attention has been placed on technologies enhancing the removal of cells, cellular debris and reduction in impurities while maintaining the antibody in the product stream. Many flocculants are systematically evaluated with respect to their mechanism of action, impact on downstream processing and product quality, and potential disadvantages. Practical considerations and future directions for application of flocculation in antibody manufacturing are discussed.