Host Cell Protein Residual Detection Kit for 293T
Host Cell Protein Residual Detection Kit for 293T
✔ Pre-coated plates save 3 hours vs. manual methods
✔ Includes FDA 21 CFR Part 11 templates
Product Description:
A sandwich ELISA for quantitative detection of host cell protein (HCP) impurities in biologics produced using 293T cell lines. Detects >95% of 293T HCP components as verified by 2D-Western blot.
Performance Specifications:
|
Parameter |
Specification |
|
Quantification Range |
37–27,000 ng/mL |
|
LOQ |
37 ng/mL |
|
Precision (Intra-run) |
CV <10% |
|
Accuracy |
85–115% Recovery |
Key Features:
Complete coverage: Detects both soluble and insoluble 293T HCPs
GMP-compatible: Meets ICH Q6B requirements
Standardized: Includes pre-diluted calibrators
Standard curve:
Datasheet:
| Component | Specification | Preparation Instructions |
| 293T HCP Coated Plate | 8 wells × 12 strips × 1 | Ready-to-use |
| Biotinylated Anti-293T HCP Antibody | 150 μL × 1 vial | Dilute 1:99 with Diluent Buffer |
| Streptavidin-HRP Conjugate | 375 μL × 3 vials | Dilute 1:9 with Diluent Buffer |
| 293T HCP Standard (81 μg/mL) | 600 μL × 1 vial | Follow recommended dilution procedure |
| Diluent Buffer | 1 g × 1 vial | Reconstitute in 100 mL 1× PBS-T (1g/100mL) |
| 10× PBS-T Wash Buffer | 50 mL × 1 bottle | Dilute 1:9 with deionized water |
| TMB Substrate | 15 mL × 1 bottle | Ready-to-use |
| Stop Solution | 15 mL × 1 bottle | Ready-to-use |
| Plate Sealer | 1 piece | Ready-to-use |
| Instruction Manual | 1 copy | - |
specification
| Assay Range | 37 - 27,000 ng/mL |
| Limit of Quantitation (LOQ) | 37 ng/mL |
| Precision | CV ≤ 10% |
| Accuracy | RE ≤ ±15% |
| Storage Temperature | 4℃ |
| Specifications | 96 well |
| LOD | 30 ng/mL |
Shipping Information
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