Product Name:293T HCP ELISA Detection Kit
This kit is designed for the quantitative detection of HCP (host cell protein) content in biopharmaceuticals expressed on 293T cells by using a double-antibody sandwich method.
This kit can be used to detect all components of HCP (host cell protein) in 293T cell.
37-27,000 ng/mL range - Broad detection capability
37 ng/mL sensitivity - Detect trace contaminants
<10% CV precision - Reliable reproducibility
Pre-coated plates - Consistent results
Ready-to-use components - Save preparation time
90-minute incubation - Faster than competitors
Clear visual protocol - Minimize operator errors
<3 hour total time - Streamline QC process
NIBSC/WHO aligned - Meet global standards
Full 293T coverage - No missed HCPs
10+ IND approved - Proven track record
8-month shelf life - Long-term reliability
1.Sample Preparation & Sample Addition
2.Incubation & Washing
3.Enzyme Conjugate & Final Washing
4.Color Development & Termination
5.Plate Reading & Analysis
Total Assay Time: Approximately 3.5 hours (including 30 minute equilibration)
| Category | Specifications |
|---|---|
| Intended Use | Quantitative detection of 293T host cell proteins (HCPs) in biopharmaceuticals using a double-antibody sandwich ELISA. For research use only. |
| Key Features | - High sensitivity: Detection range 37–27,000 ng/mL; LOQ 37 ng/mL - Precision: CV ≤10%, RE ≤±15% - Broad compatibility: Detects all 293T HCP components - Ready-to-use: Pre-coated plates, TMB substrate included. |
| Kit Components | - 293T HCP Coated Plate (96 wells) - Anti-293T HCP-Biotin (150 μL) - Streptavidin HRP (375 μL × 3) - 293T HCP Standard (81 μg/mL) - Diluent Buffer, PBS-T Wash Buffer, TMB Substrate, Stop Solution. |
| Storage & Shelf Life | 8 months at 2–8°C (protected from light). |
| Equipment Required | - Microplate reader (450 nm) - Thermostat plate shaker - Pipettes & tips - Deionized water. |
| Workflow | 1. Sample Prep: Dilute standards/samples with Diluent Buffer 2. Incubation: 1.5 h room temperature 3. Detection: Biotinylated antibody → HRP conjugate → TMB color development (15 min) 4. Readout: OD450 nm. |
| Data Analysis | 4-parameter curve fitting for quantification (example standard curve provided). |
| Turnaround Time | 3–4 hours (including incubation and development). |
| Advantages vs. Competitors | - Higher sensitivity: Lower LOQ (37 ng/mL) vs. typical 50 ng/mL kits - Optimized reagents: Pre-diluted standards reduce pipetting errors - Comprehensive QC: Includes CV/RE validation data. |
Purpose: Accurately detect residual host cell proteins (37-27,000 ng/mL) in 293T cell-derived biologics to ensure product purity and safety.
Feature:Double-antibody sandwich ELISA with pre-coated 293T-specific antibodies for superior specificity (<10% CV)
Biotin-streptavidin HRP amplification enhances sensitivity (LOQ: 37 ng/mL) versus conventional kits
Application: Critical for QC of viral vectors, recombinant proteins, and gene therapies produced in 293T cells
Technical Effort:
Validated with 8-point standard curve (4-parameter fitting, R²>0.99) and precision (RE%≤±15%)
Includes ready-to-use TMB substrate for consistent 15-min color development
Purpose: Simplify HCP testing with minimal hands-on time while meeting regulatory requirements
Feature:Pre-coated 96-well strips reduce prep time; 3.5-hour total protocol (vs. 5+ hours for competitor kits)
Pre-formulated diluents (1×PBS-T) eliminate buffer preparation errors
Application: Ideal for lot-release testing in biopharmaceutical manufacturing (e.g., AAV, lentiviral vectors)
Technical Effort:
Optimized wash steps (3×250 μL PBS-T) minimize background noise
Room-temperature incubation (18-25°C) eliminates need for precise thermal control
Purpose: Overcome matrix interference in crude supernatants and purified biologics
Feature:Broad dynamic range (37-27,000 ng/mL) accommodates both upstream and downstream samples
Included dilution buffer stabilizes HCPs and prevents false negatives
Application: Suitable for process development, in-process testing, and final product validation
Technical Effort:
Validated spike recovery (85-115%) in cell lysates and culture media
Stable 8-month shelf life at 2-8°C with light protection
Purpose: To quantify residual 293T host cell proteins in lentiviral vector batches for GMP compliance.
Feature:Broad detection range (37-27,000 ng/mL) eliminates need for sample dilution
Ready-to-use pre-coated plates save 50% hands-on time compared to traditional ELISA
Application:
Critical quality control for CAR-T cell therapy production
Validated for use with both crude supernatants and purified viral vectors
Technical Effort:
Cross-validated with mass spectrometry (R²=0.96)
Demonstrated ≤10% CV across multiple operators and instruments
Purpose: To detect low-level HCP contamination in AAV preparations.
Feature:Superior sensitivity (LOQ 37 ng/mL) outperforms commercial alternativesBiotin-streptavidin amplification enhances detection of trace HCPs
Application:
Identified HCP carryover differences between purification methods
Essential for process development and optimization
Technical Effort:
Validation against Western blot showed 100% concordance
Demonstrated <15% inter-assay variability in 20 consecutive runs
Purpose: To confirm antibody specificity for 293T HCPs without cross-reactivity.
Feature:293T-specific antibodies show <0.1% cross-reactivity
Simplified sample preparation protocol (15 minutes)
Application:
Supports regulatory filings for biosimilar development
Used for process comparability studies
Technical Effort:
Comparative testing showed 20% higher sensitivity than commercial kits
4PL curve fitting achieved R²>0.99 with automated readers
| Specification | 96 Test |
Assay range | 37-27000ng/mL |
Limit of quantitation | 37ng/mL |
Precision | CV%≤10%, RE%≤±15% |
| Validity period | 12 months |
| Storage conditions | 4℃ |
| LOQ | 37 ng/mL |
| LOD | 30 ng/mL |
| Concentration of standard（ng/mL） | OD value 1 | OD value 2 | Mean value |
| 27000 | 2.507 | 2.494 | 2.5005 |
| 9000 | 1.618 | 1.625 | 1.6215 |
| 3000 | 1.176 | 1.181 | 1.1785 |
| 1000 | 0.773 | 0.77 | 0.7715 |
| 333 | 0.496 | 0.475 | 0.4855 |
| 111 | 0.289 | 0.285 | 0.287 |
| 37 | 0.205 | 0.195 | 0.2 |
| 0 | 0.14 | 0.137 | 0.1385 |
Standard curve:
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