Residual host cell DNA is one of the typical process-related contaminants of biopharmaceutical protein preparations and the levels of host cell derived DNA have to be closely monitored and controlled throughout the production process and release of drug substance.
The IBA team has experience in developing assays for quantitative detection of residual host cell DNA impurities (both the genome and the plasmid) in recombinant proteins.
We have developed procedures for detection and quantification of residual host cell DNA contamination of recombinant human insulin as well as in recombinant hemagglutinin of H5N1 influenza virus.
We offer development of quantitative PCR assay for residual host cell DNA impurities in recombinant proteins meeting the requirements of the given project. The scope of analysis includes the step of DNA extraction, design and perform qPCR assay for the quantitative measurement of residual DNA in the test material.
LightCycler® 480II will be used to test residual DNA in provided samples.