Implementation of Mustang® Q Membrane Chromatography as a Polishing Step (Residual DNA Removal) in Monoclonal IgG1 Production from CHO Cell Culture

In collaboration with ProBioGen AG, Berlin, Germany, Mustang Q membrane chromatography was evaluated as a polishing step following protein A affinity and cation exchange chromatography to remove residual host cell DNA during a Monoclonal antibody (MAb) purification process at 250 L cell culture production-scale. Data indicated efficient DNA clearance by the Mustang Q membrane chromatography step during the process (96%). Additionally, contribution of the Mustang Q membrane chromatography polishing step to HCP removal was shown. Based on a virus-spiking scale-down study using two model-viruses (Murine Leukemia Virus (MuLV) and Minute Virus of Mice (MVM)), effective MuLV virus removal was demonstrated using Mustang Q membrane chromatography, while MVM virus clearance needed further optimization. Overall viral clearance capacity
was sufficient for manufacturing of a safe drug substance for clinical trials.