An Integrated Platform for Robust Virus and Contaminant Removal in Biomanufacturing
نویسنده
چکیده
An orthogonal virus and contaminant clearance platform including anionic membrane chromatography and nanofiltration has been evaluated as a disposable antibody polishing concept. In typical case studies, additive log reduction values (LRV’s) of > 11 could be achieved for four relevant model viruses. In the membrane chromatography step, virus removal in excess of 5 LRV was found for the four model viruses. For MVM > 6 LRV were found at a load capacity of 10.9 kg/L of Q-membrane. Mass balance data from bind & elute studies with Q membranes proved an adsorptive effect excluding any size exclusion mechanism. DNA, (> 3 logs) and host cell proteins (> 96%) were removed in the Q Membrane step. This confirmed that flow-through membrane chromatography with disposable devices is a powerful method for final purification of monoclonal antibodies and recombinant proteins with non-acidic IEP. In the virus filtration step, robust elimination of > 5 LRV for all viruses tested were obtained. Results from an economy model demonstrated that a disposable concept provides cost savings of up to 70% in MAb polishing.
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