Host Cells used for recombinant expression are complex systems containing hundreds to thousands of host cell proteins (HCPs) that can contaminate biopharmaceutical products. Failure to sufficiently remove contaminants early in drug development can result in reduced drug efficacy or adverse patient reactions.
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.
