Assurance that monoclonal antibody (MAb) therapeutics produced using large-scale animal cell culture are free of adventitious agents is based on three complementary approaches. First, a master cell bank is extensively characterized to demonstrate its freedom from adventitious agents. In addition, end-of-production cell culture material is tested and demonstrated to be free of adventitious contaminants. Finally, the viral clearance capacity of a purification process is assessed using model viruses. PRODUCT FOCUS: MONOCLONAL ANTIBODIESPROCESS FOCUS: PURIFICATIONWHO SHOULD READ: MANUFACTURING, PROCESS DEVELOPMENT, REGULATORY…