Introduction:
Researchers at the healthcare business sector of Merck in Italy are developing a proprietary Chinese hamster ovary (CHO)-based platform for enzyme-linked immunosorbent assay (ELISA) kits to monitor residual host cell proteins (HCPs) during all stages of a therapeutic’s development. In a recent study, the in-house platform was compared to a commercial kit and was found to be more accurate and reliable in quantifying CHO HCPs. This in-house platform has the potential to provide better knowledge of the manufacturing process and eliminate the need for a bridging study.
- Commercial ELISA kits lack lot-to-lot consistency and are not designed for proprietary cell lines.
- Merck researchers are developing a proprietary CHO-based platform for HCP monitoring throughout all stages of development.
- The in-house platform was found to accurately and precisely quantify CHO HCPs during early-phase product and process development.
- The in-house assay captured more HCPs than the commercial kit and showed a wider range of molecular weights and isoelectric points.
- The in-house platform has the potential to provide better process knowledge and eliminate the need for a bridging study.
Conclusion:
The development of a proprietary CHO-based platform for HCP monitoring in therapeutic development shows promising results in terms of accuracy, precision, and coverage. This in-house platform has the potential to improve process knowledge and eliminate the need for bridging studies, providing more reliable and consistent HCP monitoring throughout all stages of development.
