The CHO|360-HCP ELISA is an enhanced generic host cell protein (HCP) assay. It was designed to cover a broader spectrum of Chinese hamster ovary (CHO) host cell proteins (HCPs) than other commercially available generic HCP assays.
CHO|360-HCP ELISA is based on a unique assay design employing seperately prepared HCP antigens and antibodies from two species:
- The antigen is prepared from total and fractionated HCP obtained from the mock fermentation of CHO-K1 and CHO-S
- Specific antibodies are generated by immunizing goats (kit types A, B) and rabbits (kit types C, D)
This approach results in four different HCP ELISA kits, which together make the enhanced generic CHO|360-HCP assay.
The CHO|360-HCP ELISA method was qualified at BioGenes according to the respective ICH-Guideline ICH Q2(R1) (“Validation of analytical procedures: text and methodology“) with slightly deviations due to the nature of the method as a bioassay.
High specificity of all four antibody preparations (A to D) was demonstrated by a coverage of ≥ 80% of the CHO|360-HCP antigen distribution in 1D and 2D analysis. For each CHO|360-HCP ELISA kit (A to D), satisfying recovery was estimated in the three spiked samples within the assay working range, within the acceptance criterion 100±30% of spiked antigen. High sensitivity of CHO|360-HCP ELISA Kits (A to D), described by the validation parameter LOD, LOQ and working range, is shown below:
- LOD: 0.5 – 1.0 ng/mL
- LOQ: 2 – 3 ng/mL
- Working range: 2 – 100 ng/mL