Monoclonal antibodies (MAbs) have become the most prevalent therapeutics in the biopharmaceutical industry. Their downstream purification typically involves protein A chromatography as a capture step followed by one or two additional chromatographic polishing steps. Additional unit operations dedicated specifically for viral clearance (e.g., viral inactivation and filtration) are added to ensure product safety. According to a survey of Amgen processes, after processing through a protein A column, only trace amounts of impurities such as Chinese hamster ovary cell protein (CHOP) (<3,000 ppm), high-molecular-weight (HMW) aggregates (<6%), leached protein A (<10 ppm), and host-cell DNA (<1 ppm) need to be removed to meet final product purity specifications.
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