ABSTRACT

Another objective of the downstream purification process is viral clearance. Most biological products are produced from cell substrates and raw materials known to harbor adventitious agents. In addition, viral contamination may arise from other sources. For example, adventitious viruses can be introduced into the final product during production, and viral contamination imposes a serious manufacturing risk and needs to be strictly controlled. Therefore, there is a potential for viral contamination of biological products, and it is necessary to assess the capability of the purification process.