Host Cell Proteins (HCPs) analysis
Host Cell Proteins (HCPs) quantification after purification steps
Many New Biological Entities (NBEs) are produced through recombinant technology through host cell (e.g., bacteria, yeast or mammalian cell lines). The production of such Biologics results in a mixture of the desired product and host cell-derived impurities, including Host Cell proteins (HCPs).
Residual HCPs can potentially affect product quality, stability, and efficacy but also induce immunogenicity for treated patients. Therefore, HCPs have to be removed through the Down Stream Process (DSP) and monitored by analytical tools.
For the full HCPs analysis, different steps are mandatory from regulatory agencies (FDA, EMA).
In the early stage of Biologics manufacturing, commercial immunoassay kits are mainly used to characterize HCPs. However, HCPs coverage, identification and quantification can be limited because of the poor detection specificity.
To improve HCPs analysis, dedicated immune assay based on specific anti-HCPs are required by regulatory agencies and are then developed.
Beside, immunoassay, agencies requires supporting analysis showing the most exhaustive data completeness possible regarding dedicated HCPs characterization (identification, quantification …). LC-MS is recognized as one of the supporting technologies of choice for HCPs analysis by the regulatory agencies (USP 39).
« The use of orthogonal analytical methods (e.g. electrophoresis, HPLC, western blot, mass spectrometry) is recommended to support the development and selection of the assay, as well as the characterization of process HCPs » EDQM, BEPPA HCPs conference 2018.
To support your full HCPs characterization, ANAQUANT developed a global workflow using LC-MS. Thanks to our expertise, we will help you for:
HCP identification and quantification evaluation for:
- Generate HCPs lists in shotgun proteomics mode (protein names, molecular weight, function Isoelectric point)
- Purification step optimization.
- Batch to Batch comparison.
- Complement and characterize our ELISA.
- Identify proteases that could impact stability
- Accurate and robust HCPs of interest monitoring and quantification through every biomanufacturing step in targeted mode