CHO resDNA Quantitation Kit is designed for quantitative detection of residual CHO DNA in biopharmaceutical productions (Antibodies). Based on real-time quantitative PCR (qPCR) method, this kit makes detection the residual DNA form CHO cells rapid and reliable. The lower limit of quantitation is 3 fg/?L. All procedures are typically in less than 4 hours.
Use the kit after you extract host cell DNA from test samples. To achieve the best performances, resDNA Sample Preparation Kit (Magnetic Beads) (Cat. No. OPA-R005) is commmanded for DNA extration.
- High sensitivity for optimal product safety: LLOD (1 fg/?L) for detection of residue host cell DNA
- High specificity: No cross-reactivity with unrelated DNA
- Validation: ICH Q2(R2) as Validation of Analytical Procedures
- High-quality: This Kit is manufactured in GMP facility and alignment with the ISO 13485 standard.
The kit is used for quantitative detection of residual CHO DNA in biopharmaceutical production.
For use in quality control/manufacturing process only.
It is for research use only.
典型数据-Typical Data Please refer to DS document for The assay protocol.
Figure 1. High sensitivity and broad dynamic range using the CHO resDNA Quantitation Kit. (A) Typical analysis results obtained with Standard 1 (300 pg/μL) to 6 (3 fg/μL). (B) The standard curve of the 10-fold dilution series. PCR efficiency should be 90-110%.
Figure 2. Assay specificity. Standard curves generated using 10-fold serial dilution of CHO genomic DNA (included in the kit).
Figure 3. Consistent quantitation across a broad range of fragment sizes. Standard curves were generated using a 10-fold serial dilution of gDNA and fragmented DNA. Fragmented DNA was generated by sonicating total CHO genomic DNA (10 min, 20 min, 30min).
Figure 4. The amplification efficiency of standard curve (ACRO and Competitor J) is close to 100%, while the amplification efficiency of standard curve (Competitor H) is less than 90%.
Figure 5. The validation of spike recovery in three spike levels CHO DNA samples (high, medium, low). Results show that the recovery using the ACRO products are between 90 and 100%.
|OPA-R004-01||2×qPCR Master Mix||1.0 mL×2|
|OPA-R004-02||CHO Primer & Probe Mix||700 μL|
|OPA-R004-03||CHO DNA Control（3ng/μL）||100 μL|
|OPA-R004-04||Dilution Buffer||1.5 mL×2|
|OPA-R004-05||DNase/RNase-Free Water||1.0 mL|
Residual host cell D refers to fragments of D from the host organism that are left behind after a biological process such as the production of a biopharmaceutical product or the cultivation of a cell line. This residual D can potentially contaminate the final product and affect its safety and efficacy.?In the context of biopharmaceutical production, regulatory agencies such as the FDA and EMA have set limits on the amount of residual host cell D that is acceptable in a final product. These limits vary depending on the type of product and the route of administration, and residue host cell D quantitative kits are designed to ensure that the final product is safe for human use.?