Description
CHO Host Cell DNA Residue Detection Kit is used for the quantitative analysis of CHO host cell DNA residuce in intermediate samples, semi-finished and finished products of various biological products.
This kit adopts Taqman fluorescent probe and the polymerase chain reaction (PCR) method, which has fg level minimum detection limit and can specifically and quickly detect the residual CHO cell DNA. The kit needs to be used together with the the Residual DNA Sample Preparation Kit (Cat# 18461ES or 18469).
Features
High anti-interference capability – Reliable performance in complex sample matrices; spike recovery rates consistently between 70–130%.
High sensitivity – Lower limit of quantification (LLOQ) as low as 0.3 fg/μL.
Excellent precision – Intra-assay CV <10%; inter-assay (intermediate precision) CV <15%.
Strong specificity – Exclusively detects CHO residual DNA without interference from other genomic DNA.
Comprehensive validation – Fully validated according to ICH Q2 (R2) guidelines; complete validation reports available.
Regulatory compliance – Verified in accordance with EP 2.6.7, JP G3, and USP <63> pharmacopeia requirements, meeting international standards.
Quality assurance – All enzyme raw materials are self-developed and industrialized, ensuring stable supply and consistent quality.
Components
|
Components No. |
Name |
41332ES50 (50 T) |
41332ES60 (100 T) |
|
A |
CHO qPCR Mix |
0.75 mL |
1.5 mL |
|
B |
CHO Primer&Probe Mix |
250 μL |
500 μL |
|
C |
DNA Dilution Buffer |
2×1.8 mL |
4×1.8 mL |
|
D |
CHO DNA Control(30 ng/μL) |
25 μL |
50 μL |
Specifications
|
Linearity |
Standard curve range: 3 fg/μL – 300 pg/μL Correlation coefficient (R²): ≥ 0.98 Slope: –3.1 to –3.8 Amplification efficiency: 90%–110% |
|
Accuracy |
Recovery rate: 50%–150% (industry standard 70%–130%) |
|
Precision |
Repeatability: CV < 15% Intermediate precision: CV < 15% |
|
Sensitivity |
Limit of quantification (LOQ): 0.5 fg/μL |
|
Specificity |
No interference from other genomic DNA sources |
|
Stability |
Accelerated stability: 14 days at 37 °C Freeze–thaw stability: ≥ 10 cycles |
|
Blank Control |
No-template control (NTC): In 96 repeated qPCR runs, all Ct values ≥ 35 or no amplification observed |
|
Applicable instrument models |
Bio-Rad: CFX96 Optic Module. Thermo Scientific: ABI 7500; ABI Quant Studio 5. SLAN-96S. |
|
Application |
Detecting the residual DNA content of CHO host cells in products such as antibodies, recombinant proteins, and vaccines produced using CHO cells. |
Storage
This product should be stored at -25~-15℃ for 1 year.
Figures
1. Good Linearity
Figure 1. Standard curve (left) and amplification curve plot (right) for CHO DNA (3G).
The linear range of the CHO Host Cell Residual DNA Detection Kit (3G) is 3 fg/μL to 300 pg/μL, with an R² value of 1.0 and an amplification efficiency of 99.29%. The coefficient of variation (CV) for detection values across concentrations is <15%.
2. Sensitivity: Limit of quantification (LOQ) - 0.3 fg/μL
Figure 2. qPCR detection of CHO DNA at 0.3 fg/μL.
CHO DNA (3G) at the lowest standard curve concentration (3 fg/μL) and below was tested with 10 replicates per concentration. Results showed that at concentrations ≥0.3 fg/μL, the CV was <20%, indicating that the limit of quantification (LLOQ) of the CHO Host Cell DNA Residual Detection Kit (3G) is 0.3 fg/μL.
3. High Recovery rate: 50%–150%
Table 1. Recovery of CHO DNA in Blank Samples
Spike recovery rates for all concentrations tested were between 70% and 130%, with coefficients of variation (CV) below 20%, demonstrating consistent performance of the assay across a wide dynamic range.
Table 2. CHO DNA Recovery in Various Sample Matrices
CHO DNA (300 fg/μL) was spiked into five different background matrices (high protein, high nucleic acid, high salt, high pH, low pH) and extracted using the same procedure. Recovery rates ranged from 70% to 130%, with CVs below 20% for all matrices, demonstrating robust performance across diverse sample backgrounds.
Documents
Safety Data Sheet
Manuals
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The product is for research purposes only and is not intended for therapeutic or diagnostic use in humans or animals. Products and content are protected by patents, trademarks, and copyrights owned by Yeasen Biotechnology. Trademark symbols indicate the country of origin, not necessarily registration in all regions.
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