CHO HCP ELISA Kit (One-step), BP-QP-C035-96
One-step CHO HCP ELISA: 1.56–100 ng/mL assay range, results in under 2.5 h, no cross-reactivity with HEK293, Sf9, MDCK or E. coli HCP.
Product overview
CHO host cell proteins (HCPs) are critical process-related impurities in biotherapeutic products such as monoclonal antibodies, fusion proteins and vaccines expressed in CHO cells. Trace residual HCPs may trigger immunogenicity risks. HCP residual testing serves as a core assay item for process characterization, in-process control and product release. Critical raw materials including antigens and antibodies of this kit are independently manufactured by Zhuhai Biori Biotechnology Co., Ltd. Comprehensive method-performance validation of the kit has been conducted in accordance with the United States Pharmacopeia, Chinese Pharmacopoeia, European Pharmacopoeia and other regulations, satisfying the technical requirements for HCP testing stipulated by domestic and international biopharmaceutical regulatory authorities. The limit of detection (LOD) of the kit is approximately 0.5 ng/mL, and the limit of quantitation (LOQ) is approximately 1 ng/mL.
Features and applications
- Product type: One-step ELISA Kit
- Target Expression System: CHO
- Assay Range: 1.56-100 ng/mL
- Time to result: <2.5h
- LOD: ~0.5 ng/mL
- LOQ: ~1 ng/mL
- Specificity: No cross-reactivity with HEK 293, Sf9, P. pastoris, MDCK and E.coli HCP.
- CHO HCP ELISA Kit is intended for quantitative determination of host cell proteins (HCPs) in biological products expressed in Chinese hamster ovary (CHO) cells, including recombinant proteins, therapeutic antibodies, vaccines, and other biological products.
- The kit can quantify residual HCP in purified intermediates, drug substance, and drug product and can be used for process optimization, process monitoring, and product release.
- This is a generic kit and is not limited to a specific purification process. It broadly recognizes and detects HCPs originating from CHO-K1, CHO-DG44, CHOZN, and other CHO cell lines.
- The kit is for research use only and not intended for clinical use.
Components
| Component | Quantity | Product No. |
|---|---|---|
| CHO HCP Standards | 8 × 1 mL | BPA-003 |
| Anti-CHO HCP Microplate Strips | 12 × 8 wells | BPB-003 |
| Anti-CHO HCP:HRP(100×) | 1× 120 μL | BPC-003 |
| TMB Substrate | 1 ×12 mL | BPD-001 |
| Stop Solution | 1 × 6 mL | BPE-001 |
| Reagent Diluent | 1 × 50 mL | BPF-002 |
| Wash Concentrate(20×) | 1 × 50 mL | BPG-001 |
| Plate Sealing Film | 2 pieces | BPI-001 |
| Instruction Manual | 1 copy | / |
Performance data
Calibration Curve (Assay Range)
Description: The standards supplied with the kit and one blank sample were tested. Each concentration was tested in triplicate, and three independent runs were performed. The Calibration curve was fitted using a four-parameter logistic model.
Conclusion: In three replicate experiments, the calibration curves fitted by the 4PL model showed R² ≥ 0.99, and both RE and CV were ≤ 15% at all concentration points (≤ 20% for the highest and lowest concentrations). The assay range of the kit is 1.56-100 ng/mL.
Accuracy
Description: A calibration curve was prepared over the validated range. Five quality control (QC) levels—ULOQ, high (H), medium (M), low (L), and LLOQ—were prepared, and each level was tested in triplicate.
Conclusion: The CV and RE of the measured concentrations were ≤20%.
Repeatability
Description: A calibration curve was prepared over the validated range. High, medium, and low QC samples were prepared and tested in eight parallel replicates.
Table 1 Repeatability Test Results
| Theoretical Concentrate | HQC-60ng/mL | MQC-20ng/mL | LQC-2ng/mL |
|---|---|---|---|
| No. of Tests | 8 | 8 | 8 |
| Mean Measured Concentration(ng/mL) | 62.6 | 22.2 | 2.3 |
| Concentration CV(%) | 2.3 | 3.2 | 8.6 |
Conclusion: The CV of the measured concentrations were ≤20%.
Inter-Analyst, Inter-Day, Inter-Instrument, Inter-lot Precision
Description: Prepare calibration curve together with HQC, MQC, LQC samples for testing of inter-analyst, inter-day, inter-instrument and inter-lot precision.
Conclusion: The inter-analyst, inter-day, inter-instrument and inter-lot CV values were all below 20%, meeting the acceptance criteria.
Specificity
Description: A calibration curve was prepared over the validated range, and potential interferents were prepared in parallel. The low (L) QC level was selected as the final spike concentration.
Table 2 Specificity Test Results
| Sample | Sample concentration | Measured concentration(ng/mL) | Spike recovery |
|---|---|---|---|
| Pichia pastoris HCP | 1μg/mL | <LLOQ | 99.6% |
| E.coli HCP | 1μg/mL | <LLOQ | 90.1% |
| Sf9 HCP | 1μg/mL | <LLOQ | 79.8% |
| HEK293 HCP | 1μg/mL | <LLOQ | 100% |
| MDCK HCP | 1μg/mL | <LLOQ | 90.5% |
Conclusion: The kit showed no cross-reactivity with Pichia pastoris, Sf9, MDCK, E.coli or HEK293 host cell proteins at 1 µg/mL and the spike recoveries were within the acceptable range.
Shipping and storage
| Condition | Recommendation |
|---|---|
| Storage | Store at 2-8°C. |
| Shipping | Refer to product label and shipping documentation. |
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