Characterization of host cell proteins in the downstream process of plant-Based biologics using LC-MS profiling.

ABSTRACT: Host cell proteins (HCPs) are process-related impurities found in biopharmaceutical products that can impair their safety and efficacy. While ELISA has traditionally been employed to quantify HCPs, LC-MS emerges as a powerful alternative for precise identification of individual HCPs. In this study, we used LC-MS for profiling HCPs from Nicotiana benthamiana-derived biopharmaceuticals. Our approach involved rigorous false discovery rate control to ensure data integrity and reliability. Comprehensive analysis revealed a systematic reduction of HCPs following purification, demonstrating the efficiency of purification processes in removing non-essential proteins. Furthermore, LC-MS enabled the identification of potential contaminants, refining purification strategies and improving product puri

SUBMITTER: Panapitakkul C 

PROVIDER: S-EPMC11456875 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature