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- CHO|360-HCP ELISA Kits and Components
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CHO|360-HCP ELISA Kits and Components
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
| Type | Species | HCP |
| Type A | Goat | Total HCP |
| Type B | Goat | Fractionated HCP |
| Type C | Rabbit | Total HCP |
| Type D | Rabbit | Fractionated HCP |
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BioGenes is a highly specialized and experienced partner for challenging and customized antibody and immunoassay development projects, with a particular focus on ELISAs for quality control, diagnostics, and the development and testing of new biological therapeutics.
The Berlin-based company, which has been ISO certified since 1999, operates worldwide and maintains long-term business relationships with biotech and pharmaceutical companies, including eight of the world's ten largest pharmaceutical companies. A leading auditing firm has rated the company as one of the world's most important companies in the field of Host Cell Protein (HCP) analysis.
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