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| Product Name | CHO Residual DNA Quantification Kit |
| Catalog No. | MDKPK-0025 |
| Description | A one-tube probe qPCR kit for quantitative detection of residual CHO host-cell DNA in intermediates, bulk materials and finished biopharmaceutical products. |
| Intended Use | Residual CHO host-cell DNA testing during biopharmaceutical development, manufacturing and product quality evaluation. |
| Principle / Technology | Target-specific fluorescent probe qPCR quantifies CHO genomic DNA against supplied reference standards. |
| Detection Method | Fluorescent probe-based real-time PCR. |
| Sample Type | Biological-product and pharmaceutical intermediates, semi-finished materials and finished products after suitable residual-DNA sample preparation. |
| Performance Range / Specifications | Linear range: 0.003–300 pg/µL; reported R² 1.00 and amplification efficiency 97.94%; qPCR run time below 1 hour. |
| Sensitivity / LOD | Reported detection down to 0.0003 pg/µL; quantification limit 0.003 pg/µL with replicate CV below 20%. |
| Specificity | Highly specific for CHO DNA; no detected interference from up to 100 ng of tested human, Pichia pastoris or E. coli genomic DNA. |
| Reaction Conditions / Protocol | Add prepared sample to the one-tube probe qPCR reagent system and perform quantitative real-time PCR with the supplied reference series. |
| Components / Formulation | One-tube CHO-specific probe qPCR detection reagent system with DNA reference standards and controls. |
| Storage Conditions | Store at −30 to −15°C. |
| Package Specifications | 100 reactions. |
| Product Form | One-tube residual host-cell DNA qPCR kit. |
| Quality Control | Reference standards are calibrated against a national CHO DNA reference standard; linearity, amplification efficiency, quantification limit and specificity are assessed. |
| Key Features | Wide linear range; femtogram-level detection; strong target specificity; less than 1-hour qPCR workflow; convenient one-tube format. |
| Shipping Conditions | Ship at or below 0°C. |
| Compatibility | Suitable for residual-DNA testing workflows used with biopharmaceutical samples and compatible residual-DNA preparation methods. |
For research use only, not for clinical use.
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