Host Cell Protein Characterisation and Mass Spectrometry Strategies
19th February 2019 | 8.00 AM GMT Time, 4.00 PM Singapore time | Xuezhi Bi, Group Leader (Proteomics) /Senior Scientist at Bioprocessing Technology Institute, A*STAR |WATCH FOR FREE
Host cell proteins (HCPs) are process-related contaminants that are released to the cell culture supernatant due to secretion or lysis of host cells during the production of biologics. Due to the potential adverse effects of HCPs on the biotherapeutics stability, quality and efficacy, monitoring and clearance of HCPs is essential in manufacturing processes. Multi-analyte ELISA is the ‘gold standard’ method routinely used to detect and measure the amount of residual HCP impurities in the biologics. However, multi-analyte ELISA is expensive, laborious, and unable to detect weak and non-immunoreactive HCPs as well as to provide identity and quantity of individual HCP species. Thus, there is an increasing demand for orthogonal analytical tools, such as 2-D western blot and LC-MS/MS, to identify and quantify HCPs in the in-process intermediates and final products. Among these techniques, LC-MS/MS provides a high throughput, robust and sensitive platform to identify and quantify individual HCP, including those of low abundance. The incorporation of a quantitative MS/MS workflow supported by a comprehensive spectral library in bioprocessing strategies would enable real-time monitoring during upstream production and downstream purification of biologics, which would provide valuable information to the biopharmaceutical industry to produce safe and efficacious drugs.
Presented by Xuezhi Bi, Group Leader (Proteomics) /Senior Scientist at Bioprocessing Technology Institute, A*STAR
Dr Bi has more than 25 years of research experience on proteins and proteomics, working on samples ranging from rice, dust mites, fungus, virus, tears, sweat, cancer cell lines and tissue, embryonic stem cells, platypus venom to CHO cell-generated biotherapeutics. He obtained his PhD in 2000 from Wuhan University, followed by postdoctoral training at the International Rice Research Institute and National University of Singapore. He joined A*STAR as a research scientist, where he contributed to chemical proteomics for chemical probe/drug target identification, protein PTM and interacting partners characterization. Currently, he is leading the proteomics group at the Bioprocessing Technology Institute, focusing on mass spectrometry based biotherapeutics product CQAs characterization, identification and quantification of HCPs and aggregate-associated proteins, and proteomic profiling of upstream and downstream CHO culture processes by LC-MS. Recently, his group is actively collaborating with multiple industry partners to develop high performance LC-MS solutions for HCPs analysis and to profile mAb producing CHO cell culture processes.