HCP Analysis

Host Cell Protein Analysis

Host cell proteins (HCPs) pose a potential safety risk for biologic or proteinaceous drug compounds. Therefore, regulatory agencies demand identification and risk analysis of all residual host cell derived contaminations during the drug approval process. Even for approved drugs, HCPs need to be routinely monitored and exactly quantified in every production batch of a drug. Exact identification and quantification already at early stages of the drug development process allow focussed optimization of the purification process.

More information

Therapeutically relevant biomolecules are often produced in a biological expression system. As a consequence, remnants from the host cell can be co-purified during the manufacturing process. These host-cell proteins (HCPs) can, even at low levels, negatively impact the stability and functionality of the product. Therefore, the manufacturer needs to optimize the production process to reduce the amount of host cell derived contaminations as much as possible and to establish a surveillance process to monitor the removal of HCPs during production.

The most commonly used method to determine the amount of HCPs in pharmaceutical industry currently is ELISA. However, this method often relies on polyclonal antibodies directed against the most common HCPs or against several proteins at once. The detection and quantification of known HCPs is highly dependent on the quality of the antibodies and gives no detailed information on which proteins have been detected.

Mass spectrometry enables the unbiased detection of HCPs with high sensitivity and precision without the need for antibodies. Combined with our proprietary QconCAT technology, the detected HCPs can be quantitatively determined for each production batch.

Our PurityQuant workflow combines tools from proteomics, bioinformatics and our proprietary QconCAT technology for:

Title of the document
  1. HCP identification (PurityQuant ID)
    • Primary scanning for possible contaminants via untargeted proteomics
    • Detection of common and custom-specific HCPs
  1. HCP quantification (PurityQuant)
    • Quantitation of the detected HCPs via targeted proteomics and QconCATs
    • Routine analysis of samples during process development
  1. Clinical/manufacturing HCP assays
    • Development and validation of a custom HCP assay
    • GMP-transfer for routine testing

Our experienced professionals develop customized assays for each new project. The resulting workflows, tools and protocols will be used in-house for routine applications or can be transferred to the customer according to GMP guidelines.

Service Description Price per sample
PurityQuant ID Sensitive identification of host contaminant proteins. Includes sample preparation (tryptic digest), 4 LC-MS/MS runs (blank + three increasing concentrations) and data analysis. € 1,000.00
PurityQuant Targeted analysis, verification and absolute quantification of host contaminant proteins. Individual service as agreed with the customer
PurityQuant Gel Sensitive identification of HCPs or fragments of the major protein component from excised gel bands. Includes sample preparation (tryptic digest), LC-MS/MS and data analysis. € 400.00

Comprehensive protein quality analysis service

1) Detection

  • High resolution LC-MS/MS
  • Detection of common and custom-specific HCPs
  • Validation of the contamination’s source
Workflow for HCP analysis using LC-MS/MS.
A sample containing HCP contaminations is digested with an appropriate protease. After LC separation, the peptides are detected using high resolution mass spectrometry

2) Routine method setup

  • Targeted LC-MS/MS with low turnover time per sample
  • Accurate and precise quantification of target HCPs

3) Validation according to GMP Guidelines

  • Determination of accuracy, precision, matrix effects, linearity and more
  • Applicable to CSLI and/or FDA guidelines
In discovery proteomics, peptide features are detected in an unbiased way and selected for fragmentation. The resulting MS2 spectra are used to identify peptides. Quantification can be performed on MS1 level, i.e. on unfragmented peptides. In targeted proteomics, preselected masses are fragmented several times. Quantification is performed on MS2 level, i.e. on peptide fragments.

Our offer

Ultra-sensitive detection with high-end instruments

Protein identification with high accuracy and sensitivity

Determination of absolute amounts of protein impurities using QconCAT reference standards with a wide dynamic range

Your advantage

Antibody-free detection and quantification of host cell proteins

Surveillance of process performance at any production stage from early R&D up to routine testing

HCP detection in difficult matrices

Fast method setup without need for antibodies

You receive

Comprehensive analysis, performed and evaluated by experienced professionals

Complete reporting

Analyses and support from early R&D up to routine testing under GMP guidelines


For more information, assistance and support or to ask for a quote, please contact us

E-Mail: info[at]polyquant.com

Phone: +49 (0)9405 96999 10

Fax: +49 (0)9405 96999 28

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