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resDetect™ CHO resDNA Quantitation Kit (qPCR)

For research use only.

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  • Product Details
    CHO resDNA Quantitation Kit is designed for quantitative detection of residual CHO DNA in biopharmaceuticals (Antibodies). Based on real-time quantitative PCR (qPCR) method, this kit this kit makes the detection of the residual DNA from CHO cells rapid and reliable. The lower limit of quantitation is 3 fg/µL. All procedures are typically in less than 4 hours.

    Use this kit to detect residual DNA after the DNA is extracted from test samples. For achieving the better DNA recovery, it is recommended to use the resDetect™ resDNA Sample Preparation Kit (Magnetic Beads) (Cat. No. OPA-R005) in combination.

  • Features
    1. High sensitivity for optimal product safety: LLOD (1 fg/µL) for detection of residue host cell DNA
    2. High specificity: No cross-reactivity with unrelated DNA
    3. Validation: ICH Q2(R2) as validation of analytical procedures
    4. High-quality: This kit is manufactured in GMP facility and alignment with the ISO 13485 standard.
  • Application

    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.

  • Technical Specifications
     DNA Technical Specifications
Typical Data Please refer to DS document for the assay protocol.
 DNA TYPICAL DATA

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%.

 DNA TYPICAL DATA

Figure 2. Assay specificity. Standard curves generated using 10-fold serial dilution of CHO genomic DNA (included in the kit).

 DNA TYPICAL DATA

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).

 DNA TYPICAL DATA

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%.

 DNA TYPICAL DATA

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%.

Materials Provided
IDComponentsSize
OPA-R004-012×qPCR Master Mix1.0 mL×2
OPA-R004-02CHO Primer & Probe Mix700 μL
OPA-R004-03CHO DNA Control(3ng/μL)100 μL
OPA-R004-04Dilution Buffer1.5 mL×3
OPA-R004-05DNase/RNase-Free Water1.0 mL
  • Background
    Residual host cell DNA refers to fragments of DNA 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 DNA 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 DNA 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 DNA quantitative kits are designed to ensure that the final product is safe for human use. 
  • Clinical and Translational Updates

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