Recent advances in mammalian cell culture processes have resulted in product titers as high as 25 g/L, but have also resulted in significant increases in cell density and cellular debris compared to typical low titer cell culture processes.  Therefore, improvements in harvest processes are essential to overcome challenges associated with conventional recovery methods such as centrifugation or microfiltration.<br/>In this study, microfiltration through a hollow fiber membrane and flocculation were used as novel methods for harvesting mAb from a high cell density cell culture process.  Product quality and process performance were obtained at bench scale and compared with data from a conventional centrifuge method.  Data demonstrated that microfiltration harvest process is robust with minimal impact on product quality compared to other harvest methods.  These data provide important insights into novel harvest processes that can be easily integrated into current mAb purification platforms in order to overcome downstream processing challenges associated with high density cell cultures.<br/>

Evaluating novel harvest methods for high density mammalian cell culture processes

251st National Meeting (2016)

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