Host cell proteins are all proteins co-expressed by the host cell, apart from the therapeutic protein of interest. Residual host cell proteins (HCPs) constitute a major group of process-related impurities in a biopharmaceutical products. The risks associated with HCPs are primarily immunogenicity and can alter the therapeutic efficacy of a drug or affect patient safety. Protein recovery processes are required to minimize the content of HCPs in the final product.
Residual host cell DNA levels are another cellular contaminant present in biopharmaceuticals. The WHO, the EU and the FDA have set specific levels of residual host cell DNA that are acceptable in biopharmaceutical products.
We provide a broad range of services to analyze process-related impurities.
Host Cell Impurity testing services:
Residual Host Cell Protein (HCPs)
- ELISA
- SDS-PAGE
- Immunoblotting
Residual Host Cell DNA
- Quantitative PCR
- Dot-Blot Hybridization
Why choose Eurofins BioPharma Product Testing
- Our experienced staff has developed and qualified thousands of highly selective and sensitive methods. Our experience with these methods can help shorten your process validation and method establishment timelines and minimize costs.
- Our more then 20-year history of cGMP regulatory compliance ensures delivery of the highest quality data.
- Our expertise in biochemistry, molecular and cell biology, virology and chemistry provides you with a single source for all of your validation testing needs.
Contact us for more information about our services.
