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Article: Variables Affecting Titer And Long-Term Stability Of Virus Stocks
By Peter Romanowski, Marc Schleh, Viveka Rajurs, Shivanthi Chinniah, and Houman Dehghani
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.
Reprinted with permission from BioProcess International
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