HCP Detect™ For Host Cell Protein Detection & Monitoring
Residual host cell proteins (HCPs) is critical to drug safety, efficacy and regulatory qualification. Incomplete detection in biotherapeutics development can lead to product degradation, product instability and adverse immunogenic reactions in patients. As regulatory authorities recommend monitoring and removal guidelines, there's never been a better time for a more reliable solution.
IMPROVE YOUR RISK CONTROL STRATEGY
What is HCP Detect™?
Caprion’s state-of-the-art ProteoCarta™ mass spectrometry-based platform along with our unique HCP Detect™ solution addresses the limitations of immunoassays for HCP detection, quantification and monitoring.
Our solution provides an orthogonal method for the identification and quantitation of all types of process samples through all phases of biologics and biosimilar manufacturing to improve your risk control strategy.
How does mass spectrometry (LC-MS/MS) compares with immunoassays (ELISA)?
Although immunoassays, such as ELISA remain the gold standard, the presence of low levels of HCP requires a more sensitive method of detection. Immunoassays often don’t have the resolution to separate and detect individual HCPs.
How Mass Spectrometry Host Cell Protein Detection, HCP Detect™ Works?
Based on in-solution digestion followed by in-depth peptide analysis with LC-MS/MS.
- Unbiased (label-free, gel-free)
- High sensitivity, reproducibility
- Extensive coverage using proprietary datamining tools paired to multiple protein search
- Confident protein assignments and abundance
- Simple conversion to a quantitative multiplexed assay
HCP Quantitation, Targeted MRM
Rapid confirmation and absolute quantitation of individual HCP using highly specific and sensitive multiplexed MRM panels (LC-MRM/MS).
- 10 or more known HCPs in absolute quantitation, 100 or more in relative quantitation, all in one single assay
- stable isotope labeled (SIL) peptides for internal standards
- Precise and accurate results in ppm with precision report
- Standard curves and QC samples included
OUR EXPERIENCE. YOUR SCIENCE.
At Caprion, we have spent years collaborating with our clients on mAbs, blood products, peptides and biologics, leading the way to HCP assay development for regulatory reporting.
We also offer a fully integrated bioanalytical platform with an extensive suite of complementary assays.