The results showed a record viable cell density of 242 million cells per ml at day 15, and a record titer achievement for a Fc-fusion protein of 11.5g per liter (corrected for biomass) compared to a 1.2g per L liter titer in standard fed-batch processing.
DSM Biologics Global R&D vice president Rolf Douwenga said biopharmaceuticals can be processed at greatly reduced costs if the XD process technology combined with DSM’s proprietary Rhobust capture and clarification technology.
The Rhobust technology, an expanded bed chromatography (EBA), using cross linked agarose beads with Tungsten Carbide to increase the particle density, is applied as direct capture step for mammalian and microbial harvest to increase yields, reduce the number of unit operations and reduce process cost.
DSM Biologics has earlier reported scalability of the XD process, and demonstrated consistent results in scaling the process from 2L to 50L in its cGMP manufacturing facility in Groningen, Holland.