BIOT 478

Once highly selective Protein A affinity is chosen for robust Mab downstream process, the major role of polishing steps is to remove product related impurities, trace amount of host cell proteins, DNA/RNA, and potential viral contaminations. Disposable systems can take place as powerful alternatives either to replace polishing column chromatography or as additions to ensure product purity and excellent viral clearance power for patents' safety.

In this presentation, the implementation of three disposable systems such as depth filtration, membrane chromatography, and nanometer filtration technology in a commercial process is introduced. The excellent data set of viral clearance with these systems is presented. Application advantages and disadvantages including cost analysis are further discussed.