Afraid that specific HCPs in your drug product may halt regulatory approval?
HCPs may influence the overall safety profile of product by:
- Immunogenicity. May induce an immune response against the product by adjuvant effects.
- Homology to endogenous human proteins. Immunogenecity to induce cross reactivity against the human protein.
- Enzymatic activity. May cleave and modify the drug substance or constituents in the drug product.
- Biological activity.
- Homology to the drug substance protein.
We determine the quantity of your HCPs of concern by LC MS/MS analysis. For this purpose we identify unique signature peptides for the HCP of concern. We then use synthetic isotope-labeled signature peptides for HCP MRM quantitation. The labeled peptides are spiked into the drug sample in known amounts. We then generate standard curves for linearity and quantitative analysis. Development of the quantitation assay for in-solution samples is also possible. Furthermore, it can be used for HCPs detected by 1D and 2D Western blots.
The Host Cell Protein Analysis service includes:
- Absolute quantification of HCP of concern.
- Identification of 3 unique signature peptides for isotope labelling.
- Standard curves and linearity assessment for dilution series of drug substance and isotope labeled peptide standards.
- Quantification by peak areas in host cell proteins MRM LC-MS/MS.
If you do not know the identity of the host cell proteins in your samples, we can perform identification of HCP prior to quantification. Also take a look at our services for identification of HCPs in pre-clinical and clinical batches.