Clarification Solution for High-Density Cell Culture Harvests

Clarification of harvested cell culture broth is crucial for the efficient reuse of Protein A columns in the purification of antibodies as the plugging components, such as cells and colloids, are removed. With recent advances in mammalian expression systems, the separation process has posed challenges due to the high proportion of solids and colloids.

Traditional clarification of mammalian cell culture typically combines multiple separation technologies, usually centrifugation and depth filtration. Complexity and issues with scale-up limit the attractiveness of centrifugation. Clarification solely by depth filtration can be costly due to the high filter areas required. To overcome these obstacles, pretreatment approaches based on precipitation and flocculation have been developed.

A recently published article discusses a complete separation solution, which combines cell harvest pretreatment with pDADMAC, a polycationic flocculating agent, and depth filtration using Clarisolve® depth filters that were specifically developed for filtration of flocculated or precipitated feed streams. This next-generation clarification solution led to a robust, high yield, economical separation process with enhanced impurity removal that can be readily incorporated into current clarification platforms.

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