During biotherapeutics manufacturing, process-related impurities and other trace contaminants accompany the recombinant biotherapeutic products. Among them, host cell proteins (HCPs) are a major type of protein impurity derived from the host organism. The detection and quantification of HCPs is an area of particular concern, as these contaminants can elicit an adverse response in patients. The high complexity and the wide dynamic range of protein concentrations in the multiple purification stages of biotherapeutic production poses challenges for the traditional data dependent workflows for HCP quantification. Therefore, targeted quantitation approaches with improved sensitivity have attracted more interest in industry. Herein, a comprehensive solution for targeted HCP quantitation utilizing various LC–MS platforms is presented.
What will you learn?
- Background and relevance of host cell proteins in biotherapeutic process development.
- Analytical challenges for effective identification and quantification of HCPs
- How SCIEX’s LC–MS/MS solution can provide the most sensitivity and linear dynamic range for HCPs in highly complex samples
Who will this interest?
- Scientists, researchers or lab directors working on host cell protein analysis or those considering doing so.
Senior Manager, Global Technical Marketing BioPharma Quantification
SCIEX (MA, USA)
Lei Xiong received her PhD in analytical chemistry from the University of California, Riverside (CA, USA) in 2011. In the same year, Xiong joined SCIEX (MA, USA) as an Application Scientist to support LC–MS demonstration and workflow development. Xiong started to take global application lead responsibility for peptide quantitation in 2015 and became the Senior Manager of Advanced Workflow Development & Method Factory in SCIEX to lead total solution development in life science in 2017. In the following year, Xiong joined SCIEX biopharma business unit to manage global technical marketing in the biopharma quantification area.
In association with