Unbeatable sensitivity with unbiased host cell protein detection

Biotherapeutics utilize common cell lines for production, but during the production process, proteins from the host cells can be co-purified with the therapeutic, resulting in contamination. These residual host cell proteins (HCPs) can adversely affect drug safety, so it is critical that these HCP contaminants are accurately detected and identified during biotherapeutic development.

A common technique for detecting these contaminants is the use of an ELISA assay, developed with polyclonal antibodies raised against the host cells. These assays can take up to several months to develop and are typically capable of detecting the majority of HCPs, particularly those proteins that are highly abundant or highly immunogenic. However, detection of "the majority" simply isn’t good enough to guarantee the safety of the final biotherapeutic product, as undetected proteins that are immunogenic in humans can cause a serious reaction.

As a result, orthogonal detection and monitoring techniques, such as LC-MS/MS and CESI-MS/MS are increasingly used to supplement ELISA methodologies. LC-MS/MS enables you to not only fully detect and characterize HCPs in a biologic preparation, but also get individual protein identity information directly from the acquired data, rather than simply a number for the total sum of HCA, which is a current limitation of ELISA-based methods.

SCIEX offers a powerful solution with SWATH acquisition on a TripleTOF system. The data-independent acquisition (DIA) strategy provides unbiased sampling for detection of low-level HCPs—even those that were previously unknown or did not generate an immunogenic response in animal studies.

SCIEX offers a leading solution to the challenges presented by low-level host cell proteins (HCPs), enabling safe biotherapeutic development with proven technologies that can help you boost productivity.

If you are responsible for monitoring host cell proteins that may contaminate a drug product preparation, you need to identify low-level proteins and monitor their presence during processing to ensure they are cleared before the drug product is released. SCIEX provides a solution that enables you to dig deeper into a complex sample, with both very high- and very low-abundance analytes, to find and monitor host cell proteins with confidence and in a single injection.