| 摘要： |
Traditional purification platforms for monoclonal antibodies (mAbs) rely heavily on 3-4 step chromatographic operations with protein A affinity chromatography as the essential antibody capture approach. In this study, we applied for the first time the established fatty acid-mediated chromatin-directed clarification to cell fermentation broth. An efficient chromatin-directed cell culture fluid (CCF) clarification process was developed to remove most host DNA and histones, as well as reduce non-histone host cell proteins (n-h HCPs) by 94.7%, with a 92.5% IgG recovery yield. The pre-removal of a large amount of host cell contaminants allows tangential flow filtration (TFF) to concentrate clarified cell culture supernatant (CCS) and perform buffer exchange. High-capacity cation exchange chromatography (CEX) was shown to effectively remove the remaining host impurities. This new antibody purification platform achieves an 86.7% antibody recovery yield with an end-product meeting all clinical requirements, greatly shortening the antibody purification process and improving the antibody production efficiency. |
