E. coli residual DNA quantitative Kit is designed for quantitative detection of residual E. coli DNA in biopharmaceutical productions (Antibodies, CAR cell, Vaccines, etc.). Based on real-time quantitative PCR (qPCR) method, this kit makes detection the residual DNA form E. coli bacteria rapid and reliable. The lower limit of quantitation is 3 fg/?L. All procedures are typically in less than 4 hours.
- 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 E. coli DNA in biopharmaceutical production.
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 E. coli residual DNA quantitative 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 E. coli 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 E. coli genomic DNA (8min, 13min, 20min). Fragmentation of the DNA was confirmed by agarose gel analysis.
Figure 4. The amplification efficiency of standard curve (ACRO and Competitor T) is close to 100%, while the amplification efficiency of standard curve (Competitor H) is less than 90%.
Figure 5. Validation of the recovery in four different E. coli DNA samples (gDNA 180 pg, gDNA 1.8 pg, Fragmented DNA 180 pg, Fragmented DNA 1.8 pg). Results show that the recovery using the ACRO products are between 90 and 100%.
|OPA-O002-01||2×qPCR Master Mix||1.0 mL×2|
|OPA-O002-02||E. coli Primer & Probe Mix||700 μL|
|OPA-O002-03||E. coli DNA Control（3ng/μL）||100 μL|
|OPA-O002-04||Dilution Buffer||1.5 mL×2|
|OPA-O002-05||DNase/RNase-free Water||1.0 mL|
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.?