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resDetect™ E1A&SV40LTA resDNA Quantitation Kit (qPCR)

For research use only.

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  • Product Details
    E1A&SV40LTA resDNA Quantitation Kit is designed for quantitative detection of residual E1A and SV40LTA DNA in biopharmaceutical productions (cells, viruses, etc.). Based on real-time quantitative PCR (qPCR) method, this kit makes detection the residual DNA rapid and reliable in one reaction. The lower limit of quantitation is 40 copies/µL. 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 commanded for DNA extraction.

  • Features
    1. High sensitivity for optimal product safety: LLOQ (40 copies/µL) for detection of residue 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 E1A&SV40LTA 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 E1A&SV40LTA resDNA Quantitative Kit. (A) Typical analysis results of obtained with E1A DNA Control Standard 1 (4×10⁶ copies/µL) to 6 (4×10 copies/µL). (B) The standard curve of the E1A DNA Control 10-fold dilution series. PCR efficiency should be 90-110%. (C) Typical analysis results of obtained with SV40LTA DNA Control Standard 1 (4×10⁶ copies/µL) to 6 (4×10 copies/µL). (D) The standard curve of the SV40LTA DNA control 10-fold dilution series. PCR efficiency should be 90-110%.

 DNA TYPICAL DATA

To evaluate the specificity of assay using E1A&SV40LTA resDNA Quantitation Kit, no template samples spiked with unrelated DNA were tested. Results shown in the following Table. Unrelated DNA (CHO, Vero, Pichia yeast) were not detected in assay, and the values of E. coli and MDCK were outside the range of standard curve (4×10⁶ copies/µL to 4×10 copies/µL).

 DNA TYPICAL DATA

To evaluate the recovery of assay using E1A&SV40LTA resDNA Quantitation Kit, three different concentrations of DNA samples were tested. Results shown in the following Table. All samples had recoveries between 78%-100%.

Materials Provided
IDComponentsSize
OPA-R007-01E1A&SV40LTA Primer & Probe Mix550 μL
OPA-R007-022×qPCR Master Mix1.6 mL
OPA-R007-03Linearize DNA Control 4×10⁸ copies/μL50 μL
OPA-R007-04DNA Dilution Buffer1.5 mL×3
  • 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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