The economics of the protein A capture step in mAb purification rely on effective resin utilization over multiple cycles. To this end, pDADMAC-based flocculation and subsequent filtration with gradient depth filters was evaluated as a method of cell culture clarification to reduce the impurity burden on protein A resin. The effects on column performance, measured using yield, binding capacity, backpressure, and impurity clearance, were investigated over 160 cycles. Results were compared with a lifecycle assessment of protein A capture of the same feed stream clarified using traditional depth filters without flocculation. Improvements in maintenance of dynamic binding capacity, column backpressure evolution over number of cycles, and host cell protein (HCP) levels in protein A eluate were observed. Process consistency in terms of product concentration in the eluate and eluate volume was also maintained over the 160 cycles. Cost of goods analysis was performed to quantify the economic benefits of the enhanced clarification strategy on the holistic clarification and capture process. Additional wash optimization to further improve the HCP clearance is currently being investigated.

Improvement in protein A resin lifetime by implementing poly-diallyldimethylammonium chloride (pDADMAC) flocculation coupled with gradient depth filtration

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.