Researchers from Merck Serono S.p.A., led by Elisa Giordano and Irene Cecchini, along with the team including Roberta Verani, Barbara Liori, and Lidia Leone, have developed an innovative in-house platform for monitoring host cell proteins (HCPs) in biopharmaceutical production. This advancement is crucial in ensuring the quality, safety, and efficacy of recombinant therapeutic products. Their findings were published in the European Journal of Pharmaceutical Sciences.
The team at Merck Serono, focused on creating a reliable and efficient platform for HCPs ELISA (enzyme-linked immunosorbent assay) monitoring. Traditional commercial ELISA kits, typically used during early drug development stages, often lack specificity and consistency. They are not tailored to a manufacturer’s proprietary cell line, which can lead to variability in results. To address these challenges, the researchers designed a platform-specific assay using Chinese Hamster Ovary (CHO) cells, the most widely used cells for producing recombinant proteins.
Elisa Giordano stated, “The in-house CHO HCP platform we developed aims to provide higher sensitivity and better coverage compared to commercial ELISA kits. This allows for more accurate and precise quantification of HCPs, ensuring the purity of biopharmaceutical products.” The work was published in the peer-reviewed journal, European Journal of Pharmaceutical Sciences.
The researchers utilized advanced electrophoresis techniques, including 2D SDS-PAGE and 2D DIGE, to select the best antigen-antibody pair for their ELISA platform. This rigorous selection process ensured that their in-house platform could effectively recognize and quantify HCPs throughout the different stages of drug development. The study demonstrated that their platform provided superior sensitivity and specificity, outperforming commercial kits, particularly in later stages of product development.
The in-house platform’s effectiveness was evaluated through a series of experiments. These included comparing the platform’s performance with commercial ELISA kits, assessing sample linearity and accuracy, and conducting a coverage study to determine the platform’s ability to detect a wide range of HCPs. The results showed that the in-house platform consistently provided more accurate and reliable data, making it a promising tool for ensuring product quality in biopharmaceutical manufacturing.
Irene Cecchini highlighted the significance of their findings, “Our platform not only meets but exceeds the sensitivity and coverage requirements outlined in the USP General Chapter <1132>. This ensures long-term sustainability and reliability for monitoring HCPs in biopharmaceutical production.”
In summary, the development of the in-house CHO HCPs platform represents a significant advancement in the biopharmaceutical industry. By providing a more accurate, sensitive, and consistent method for monitoring HCPs, this platform enhances the ability to ensure the safety and efficacy of recombinant therapeutic products. The researchers at Merck Serono have set a new standard for HCP monitoring, which could lead to better quality control and improved outcomes in drug development and manufacturing.
Journal Reference
Giordano, E., Liori, B., Cecchini, I., Verani, R., & Leone, L. (2024). “In-house CHO HCPs platform: A promising approach for HCPs ELISA monitoring.” European Journal of Pharmaceutical Sciences. DOI: https://doi.org/10.1016/j.ejps.2023.106656
