Before approving a biologic or proteinaceous drug compound, regulatory agencies demand that all residual host cell derived contaminations are identified and quantified.
As therapeutically relevant biomolecules are often produced in an appropriate expression system, remnants from the host cell can be co-purified during the production process. These host cell proteins (HCPs) could, even at low levels, negatively impact the stability and functionality of the product. Therefore, the manufacturer needs to establish processes to reduce the amount of host cell derived contaminations as much as possible.
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.
Using our LC-MS/MS technology we offer both primary scanning for possible contaminants via untargeted proteomics and full method setup for routine scanning of known common contaminants via targeted proteomics.
PolyQuant’s technology supports both exact identification of formerly unknown custom-specific HCPs and absolute quantification of common HCPs and can be applied to every production organism, as well as cell-free production and complex matrices. Our standardized assay allows controlling HCPs already at a very early time point in product development. Custom-made isotope labelled standards enable us to set up GMP conform routine measurements for any proteinaceous contaminant.
|Service||Description||Price per sample|
|PQ-HCP-identification||Sensitive identification of host contaminant proteins. Includes sample preparation (tryptic digest), LC-MS/MS and data analysis (list of detected proteins, estimation of abundance)||€ 1,000.00||
||Targeted analysis, verification and absolute quantification of host contaminant proteins. Individual service as agreed with the customer
Special offer price valid for orders until 31.12.2022
Comprehensive protein quality analysis service
- High resolution LC-MS/MS
- Detection of common and custom-specific HCPs
- Validation of the contamination’s source
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
Protein identification with high accuracy and sensitivity
Determination of absolute amounts of protein impurities using QconCAT reference standards with a wide dynamic range
Antibody-free detection and quantification of HCPs
Surveillance of process performance at any production stage from early R&D up to routine testing
HCP detection in difficult matrices
Fast determination of relative amounts
Comprehensive analysis, performed and evaluated by experienced professionals
For more information, assistance and support or to ask for a quote, please contact us: