Researchers at Merck Serono SPA led by Elisa Giordano and Irene Cecchini, as well as teams including Roberta Vrani, Barbara Liori and Lidia Leone, have developed an innovative internal internal platform to monitor the host cell protein (HCP HCP HCP in biological drug production production (HCP HCP To. This progress is essential for ensuring the quality, safety and efficacy of reorganization. Their discovery was published in the European Pharmaceutical Magazine.
Merck Serono’s team is committed to creating a reliable and efficient platform for HCPS Elisa (enzyme -linked immune adsorption measurement method). Traditional commercial ELISA kits used in early drug development phase usually lack specificity and consistency. They are not tailor -made for manufacturers’ proprietary cell lines, which may lead to changes in results. In order to cope with these challenges, the researchers designed a platform -specific determination using the Chinese hamster ovarian (CHO) cells, which is the most widely used cell used to produce recombinant proteins.
ELISA GIORDANO said: “Compared with the commercial Elisa kit, the internal Cho HCP platform we developed aims to provide higher sensitivity and better coverage. This allows HCP to be more accurate and more accurate to ensure biopharmaceuticals to ensure biopharmaceutical drugs. The purity of the product “is published in the Journal of Peer Review and” European Pharmaceutical Magazine “.
Researchers use advanced electrophoretic technology including 2D SDS-Page and 2D DIGE to select the best antigen antibody pair for its ELISA platform. This strict choice process ensures that their internal platforms can effectively identify and quantify HCP effectively at various stages of drug development. The study shows that their platform provides excellent sensitivity and specificity, surpassing business suits, especially in the later stages of product development.
The effectiveness of the internal platform was evaluated through a series of experiments. These include comparing the performance of the platform with the commercial ELISA kit, evaluating the linearity and accuracy of the sample, and the ability to conduct coverage to determine the ability to detect a wide range of HCP. The results show that internal platforms have always provided more accurate and reliable data, making it a promising tool to ensure the quality of biopharmaceutical manufacturing products.
Irene Cecchini emphasizes the importance of their discovery: “Our platform is not only satisfied, but also exceeds the sensitivity and coverage requirements of the general chapter in USP. Long -term sustainability and reliability.
In short, the development of the internal Cho HCPS platform represents major progress in the biopharmaceutical industry. By providing more accurate, sensitive and consistent methods for monitoring HCP, the platform enhances the ability and efficacy of ensuring the safety and efficacy of reorganizing products. Researchers at Merck Serono have set new standards for HCP monitoring, which may lead to the results of quality control and improvement of drug development and manufacturing.
Journal reference
Giordano, E., LIORI, B., CECCHINI, I., Vrani, R. And leone, L. (2024). “Internal Cho HCPS platform: HCPS Elisa monitoring has a promising method.” European Pharmaceutical Magazine. DOI:
