Monoclonal Antibody Aggregate Polish and Viral Clearance Using Hydrophobic-Interaction Chromatography

Hydrophobic Interaction chromatography (HIC) is a powerful polishing tool for the downstream purification and manufacture of biotherapeutics. HIC offers orthogonal selectivity for the clearance of difficult process and product-related impurities such as aggregates, host cell proteins and endogenous and adventitious viruses.  In this study, a family of POROS HIC resins with novel ethyl and benzyl chemistries was used to successfully polish two clinical stage monoclonal antibodies harboring very high levels of product aggregation (>10%). In addition to aggregate removal, viral clearance using optimized HIC processes was also extensively studied though the use of a novel prediction technique centered on a parvovirus surrogate “Mock Virus Particle” (MVP) combined with live virus “spiking” data using xenotropic murine leukemia virus (XmuLV) and minute virus of mice (MVM). The results from these studies demonstrate the high productivity aggregate and viral clearance capability of POROS HIC chromatography resins and the value of utilizing MVP as a non-infectious tool for process development and characterization.

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