Host Cell Protein Analysis ELISA Kits

The number of protein based drugs coming onto the market is at an all-time high,particularly those produced with a host cell system.With host cells come their own proteins. These host cell proteins(HCPs) constitute a major part of process-related impurities and can adversely affect drug safety,so it is critical that they are identified and quantified accurately. HPCs can get detected when using immunoassays,such as enzyme-linked immunosorbent assays(ELISAs).
Regulations require HCPs be reduced to the lowest levels possible. Our generic ELISA kits are useful in both process development and process validation. Using these kits in the earliest phase of product development can provide relevant and specific data directing process improvement and decreasing the levels of HCP contamination.
In quality control applications, subject to thorough validation and qualification by each laboratory, these kits may also be useful for lot release testing.