Anaquant HCP analysis I Protein characterisation I Protein analysis
The first validated kit for HCP quantification using mass spectrometry
The first validated kit for HCP quantification using mass spectrometry
54 proteotypic peptides adsorbed on READYBEADS to obtain a universal internal calibration curve
This application use the TOP3 approach to convert MS signal of each identified HCP into ppm or ng/ml
Thanks to the internal calibration curve, get a QC of each analysis. Don't wait your QC sample to see if everything goes well.
Cutting-Edge Host Cell Protein Analysis for Biopharmaceuticals
The HCPprofiler kit from ANAQUANT is a premier solution designed to accurately and efficiently identify and quantify host cell proteins (HCPs) in biopharmaceutical samples using advanced LC-MS/MS technology. The kit combines innovative standards and proprietary software to deliver unparalleled precision and reliability, ensuring compliance with stringent regulatory requirements.
Thanks to our dedicated software, it becomes easy to compare protein quantity between different batch production of each HCPs within all production batches.
Key Features:
Comprehensive and Accurate Detection: Leveraging quantitative LC-MS/MS analysis, the HCPprofiler kit accurately identifies and quantifies a wide range of HCPs, ensuring thorough impurity profiling for biopharmaceutical products.
High Sensitivity and Specificity: With the integration of ANAQUANT’s READYBEADS technology, the kit offers a robust internal calibration curve, enhancing the sensitivity and specificity of HCP detection, even in complex matrices.
User-Friendly Workflow: The kit features a straightforward protocol for sample preparation and analysis, including denaturation, reduction, alkylation, and enzymatic digestion, followed by nanoLC-MS/MS analysis. This user-friendly approach simplifies the integration into existing workflows.
Regulatory Compliance: The HCPprofiler kit meets the ICH Q2(R2) guidelines for analytical procedures, ensuring compliance with global regulatory standards for impurity testing.
Why Choose HCPprofiler?
With its advanced technology, high accuracy, and robust performance, the HCPprofiler kit is the preferred choice for biopharmaceutical companies seeking reliable and efficient HCP analysis. Ensure the safety and efficacy of your bioproducts with the comprehensive and precise HCPprofiler kit.
Advantages:
Accuracy: The HCPprofiler standard demonstrates high accuracy, with quantification error ranges between 0.8 to 1.2, validated through rigorous testing against known standards.
Precision: The kit exhibits excellent precision, with repeatability coefficients of variation (CVs) ≤ 15% for intra-batch and intermediate precision, ensuring consistent results across different conditions and batches.
Reproducibility: The HCPprofiler kit maintains reproducibility with CVs ≤ 25% across different instruments and laboratories, confirming its robustness and reliability.
Specificity: The READYBEADS technology ensures specificity by using peptides that do not correspond to any known proteomes, minimizing interference and enhancing the accuracy of HCP quantification.
Robustness: The method is validated for robustness, maintaining performance across various sample matrices, instruments, and operators, proving its reliability under different conditions.
Wide Working Range: The HCPprofiler kit offers a linear quantification range from 1 to 500 fmoles, ensuring accurate detection across a wide concentration range.
Cross Validation: The HCPprofiler quantification method shows strong correlation with the gold standard SRM method, validating its efficacy in both purification intermediates and drug product samples.
> Ideal for monitoring HCP levels during the development of therapeutic proteins and biologics.
> Ensures consistency and safety by providing reliable HCP quantification in final product release testing.
> Aids in refining purification processes to enhance product purity and quality.