Host Cell Protein Analysis
Identification and risk analysis of all residual host cell derived contaminations is crucial for the approval process of biologic or proteinaceous drug compounds.
Exact identification and quantification already at early stages of the drug development process allow focussed optimization of the purification process.
Our established workflows combine tools from proteomics, bioinformatics and our proprietary QconCAT technology for standard analyses or development of customized assays for HCP monitoring during drug development and production processes.
More information
Host cell proteins (HCPs) pose a potential safety risk for biologic or proteinaceous drug compounds. As therapeutically relevant biomolecules are often produced in a biological expression system, 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, 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. To address the regulatory requirements, manufacturers need 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. Our mass spectrometry based technology 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.
HCP Analysis Services
PurityQuant ID
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HCP identification
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Primary scanning for possible contaminants via untargeted proteomics
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Detection of common and custom-specific HCPs
Includes sample preparation (tryptic digest), 4 LC-MS/MS runs (blank + three increasing concentrations) and data analysis.
Price per sample
€ 1000,-
Custom HCP Assay
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Clinical/manufacturing HCP assays
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Development and validation of a custom HCP assay
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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.
Comprehensive protein quality analysis service
1) Detection
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High resolution LC-MS/MS
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Detection of common and custom-specific HCPs
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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
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Targeted LC-MS/MS with low turnover time per sample
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Accurate and precise quantification of target HCPs
3) Validation according to GMP Guidelines
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Determination of accuracy, precision, matrix effects, linearity and more
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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.
ELISA-free host cell protein (HCP) analysis
Established LC-MS/MS workflows and bioinformatics analyses for surveillance of process performance and quality control of e. g. recombinant proteins, vaccines, biotherapeutic formulations, protein purifications etc.
Individual service
Receive customized HCP analysis services with clear timelines, milestones, deliverables and detailed reporting.
Support
Our experienced team provides consulting and support at every stage of the project. From early R&D up to routine testing under GMP guidelines.
Scalable
From exploratory studies to routine measurements and high throughput analyses.
High sensitivity
Ultra-sensitive and unbiased protein detection with high-end instruments
Antibody-free
Antibody-free detection and quantification of host cell proteins with high accuracy and sensitivity
Fast method setup
HCP detection in difficult matrices without requiring lengthy antibody production or ELISA development.