De-risk Development and Improve Your Control Strategy with HCP Detect
Comprehensive HCP Analysis via Mass Spectrometry
Residual host cell proteins (HCPs) are unavoidable in biopharmaceuticals.
They can be immunogenic, exhibit drug-modifying activity, and co-purify at high levels, which may pose a safety risk.
To ensure patient safety and product efficacy during manufacturing, regulatory guidance recommends using orthogonal analytical technologies to confirm and supplement HPC ELISA data while mitigating the risk of using a single technology.
CellCarta’s HCP Detect™ identifies and tracks HCPs to improve product purity and optimize process engineering.
Experts helping you move forward with reliable data
Each assay is performed with the same rigor and attention to detail by accomplished CellCarta scientists and bioinformaticians.
HCP Detect™ uses proven, state-of-the-art mass spectrometry platforms to provide a comprehensive, sensitive, and specific characterization of HCPs in your Drug Substance (DS) or Drug Product (DP).
Each HCP analysis is conducted using highly controlled, robust, and documented processes.
Applications:
- HCP profile – originator versus biosimilar
- Purification process optimization – to identify problematic HCPs
- HCP clearance monitoring – to identify key clearance steps
- Validation runs reproducibility – process characterization
HCP Detect™ - Two options depending on your objective
1- Comprehensive list of all HCPs and their respective abundance
- HCP identification and quantitation using unbiased LC-MS/MS
- Sensitivity down to ~1-10ppm (protein and sample-dependent)
- Direct measurement that does not require antibodies
- Custom process-specific database containing the entire host proteome for comprehensive protein identification
- No need for assay or reagent development
2- Absolute quantification of specific HCPs
- Highly multiplexed measurement using targeted LC-MRM/MS
- Absolute quantitation (≤10-15HCPs) and/or relative quantitation (≤325 HCPs) in a single assay
- Quick assay development based on target protein sequence(s)
- Sensitivity down to single-digit ppm
- Stable isotope labeled (SIL) peptides as internal standards
- Assays can be fully validated as per regulatory requirements
