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High Sensitivity Host Cell Detection Kits
Ensure the quality and safety of your product(s)
Your complete host cell impurity panel.
Protein and DNA impurities carry different risks and require different tests. Our new high-sensitivity HCP ELISAs and HCD kits cover both, each validated per ICH Q2(R2), with the full validation report included at no extra cost.
The complete impurity panel
Two impurities. Two risks.
One panel.
A clean HCP result tells you nothing about residual DNA. Regulators expect both to be measured and controlled, so your release panel needs both tests.
High-Sensitivity HCP ELISA
Residual host cell proteins
Co-purified proteins that can trigger immune responses, speed up drug degradation or raise questions in regulatory review. ICH Q6B and agency guidance expect HCP clearance to be demonstrated and documented for every biologic and CGT program.
HCD Kits · qPCR & dPCR
Residual host cell DNA
Residual genomic DNA carries oncogenic and immunogenic risk and must be controlled below 10 ng per dose. Choose qPCR or dPCR for orthogonal quantification down to femtogram levels.
Full panel
Complete host cell impurity testing
Both assays from one ISO 13485 certified US facility. Qualify once, with validation reports in every box.
Why Enzo
Built for teams where audit readiness is non-negotiable.
Validation report included – no extra cost
Many suppliers leave you to generate or buy kit-level validation data yourself. Every Enzo kit is validated per ICH Q2(R2) (2023) and includes the full kit-level AMV report at no extra cost:
Validate once. Supply through launch.
Large production lots mean the same antibody preparation from early development through BLA filing and commercial manufacturing, with no mid-program lot change to trigger re-validation.
Four ways our HCP and HCD kits fit your QC workflow.
Catch what others miss.
Our CHO HCP ELISA pairs a proprietary polyclonal antibody mix with coverage of the three most widely used CHO lines, and our E. coli HCP ELISA is validated across four common strains. We went further than strain coverage: 4D-DIA LC-MS profiling against ~1,700 CHO and ~2,500 E. coli proteins confirmed detection of the key co-purifiers, including PLBL2, Clusterin, LPL and Cathepsins B/D/Z in CHO, and SlyD, DnaK, GroEL and Flagellin in E. coli. The result: fewer host cell protein contaminants slip through your process unnoticed.
Clear impurities. Keep your yield.
Every extra polishing step costs product. Sensitive, precise HCP and HCD data shows exactly how much clearance each step delivers, so you can remove impurities without over-purifying and protect the yield of every batch.
Less time at the bench, faster results
HCP results in under 3 hours. Straightforward protocols cut hands-on time and fit straight into your QC workflow, so release decisions come sooner.
No additional investment.
No proprietary instrument required. The HS-HCP ELISAs run on any standard microplate reader, and the HCD kits work with any qPCR or dPCR platform. Set up in your existing lab, with no capital spend.
Contact us
Talk to our experts.
Questions about HCP or HCD testing, validation data or pricing? Send us a message and a specialist will get back to you.
- Kit selection and sample requirements
- Validation reports and documentation
- Quotes and bulk orders
- Sample requests
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