Host Cell Protein management
Host Cell Protein (HCP) Management
Ensure the Safety and Quality of Your Biotherapeutics
Bioproduction processes rely on a wide range of host cell systems—including bacterial, yeast, mammalian, insect, and plant cells—to produce the therapeutic proteins used in modern medicine. However, these systems also generate unintended protein contaminants, known as host cell proteins (HCPs), which can compromise drug safety, efficacy, and purity.
Why HCP Monitoring Is Critical?
HCPs are residual impurities that, if not effectively removed, may lead to:
- Reduced therapeutic efficacy
- Adverse immune responses
- Stability issues over the product lifecycle
To comply with global regulatory standards (EMA, FDA, ICH) and ensure patient safety, biopharmaceutical companies must implement robust HCP monitoring and removal strategies throughout the development and manufacturing process.
Validated Detection with ELISA: The Gold Standard
At CliniSciences, we provide validated, industry-trusted ELISA kits for the sensitive detection and quantification of HCPs. The sandwich ELISA method remains the gold standard for HCP monitoring, offering:
- High sensitivity and specificity
- Reproducible results
- Compliance with regulatory requirements
Our HCP ELISA Kit Portfolio
We offer a comprehensive range of HCP ELISA kits, carefully selected for different host cell systems:
- CHO HCP ELISA Kits (Chinese Hamster Ovary)
- E. coli HCP ELISA Kits
- HEK293 HCP ELISA Kits
- Yeast HCP ELISA Kits
- Insect Cell HCP ELISA Kits (Sf9, Sf21)
- Plant Cell HCP ELISA Kits
Each kit is supplied with validated antibodies, a detailed protocol, and quality controls for optimal performance across research, process development, and GMP manufacturing environments.
Partner With CliniSciences
With years of expertise in bioproduction support, CliniSciences is your trusted partner for HCP monitoring and quality control. Whether you're in early-stage development or commercial production, we provide:
- Scientific support and consultation
- Regulatory guidance
- Custom HCP assay solutions
Let us help you ensure biotherapeutic integrity and patient safety—from research to release.