HCPprofiler qualification report

The HCPprofiler Standard Qualification Report validates ANAQUANT’s HCPprofiler kit for precise identification and quantification of Host Cell Proteins (HCPs) using LC-MS/MS. The report confirms:

• Scope: The HCPprofiler combines a peptide-coated bead standard and proprietary software to generate calibration curves for HCP quantification.
• Validation: The method demonstrates strong specificity, accuracy, precision, and robustness, adhering to ICH Q2(R2) guidelines. Validation covers a broad working range (1-500 fmol), with high linearity (R² ≥ 0.90), accuracy (82%-119%), and repeatability (CVs ≤ 15%).
• Reproducibility: Tested across batches, instruments, and labs, showing CVs ≤ 21%.
• Application: Successfully quantifies HCPs in therapeutic peptide drug substances with high repeatability.

The report concludes that the HCPprofiler kit is a reliable and robust tool for accurate HCP quantification in various matrices.

Click here for full qualification report