Optimized Continuous Multicolumn Chromatography Enables Increased Productivities and Cost Savings by Employing More Columns.

The advantages of continuous chromatography with respect to increased capacity are well established. However, the impact of different loading scenarios and total number of columns on the process economics has not been addressed. Here four different continuous multicolumn chromatography (MCC) loading scenarios are evaluated for process performance and economics in the context of a Protein A mAb capture step.

Scale-up of continuous multicolumn chromatography for the protein a capture step: From bench to clinical manufacturing.

The awareness about implementing continuous processing for biopharmaceutical products has significantly increased throughout the recent years not only at developmental scale but also for phase I supply in clinical trial manufacturing. In this study, we focused on upscaling continuous protein A chromatography from lab to pilot scale using the Cadence™ BioSMB PD and the Cadence™ BioSMB Process 80 system, respectively. Additionally, we evaluated hardware and software capability whilst running the system for 10 days non-stop using feed from a perfusion bioreactor.

Phase behavior of an intact monoclonal antibody.

Understanding protein phase behavior is important for purification, storage, and stable formulation of protein drugs in the biopharmaceutical industry. Glycoproteins, such as monoclonal antibodies (MAbs) are the most abundant biopharmaceuticals and probably the most difficult to crystallize among water-soluble proteins. This study explores the possibility of correlating osmotic second virial coefficient (B(22)) with the phase behavior of an intact MAb, which has so far proved impossible to crystallize.