Work

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

Year: 2024

Type: article

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 purity and integrity. Our findings highlight the potential of LC-MS as an analytical tool for HCPs analysis in biopharmaceutical development and manufacturing. By providing detailed insights into HCPs profiles and contaminants, LC-MS facilitates informed decision-making in downstream processing steps, benefiting product quality, patient safety, and the biopharmaceutical sector.

Source: Biotechnology Reports

DOI: 10.1016/j.btre.2024.e00856

Authors: Chalisa Panapitakkul, Christine Joy I. Bulaon, Nuttapat Pisuttinusart, Waranyoo Phoolcharoen

Institution: Chulalongkorn University

Language: English

Topic: Transgenic Plants and Applications

Subfield: Biotechnology

Field: Biochemistry, Genetics and Molecular Biology

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,070