膜杰作
Star Staining
产品描述（Product Details）
Plasmid resDNA Quantitation Kit is designed for quantitative detection of residual plasmid 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. The lower limit of quantitation is 40 copies/µL using the Linearize DNA Control in the assay. 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.
产品特性（Features）
- High sensitivity for optimal product safety: LLOQ is 40 copies/µL using Linearize DNA Control in this assay
- 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.
应用说明（Application）
The kit is used for quantitative detection of residual Plasmid DNA in biopharmaceutical production.
For use in quality control/manufacturing process only.
It is for research use only.
技术参数（Technical Specifications）
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 Plasmid resDNA Quantitation Kit. (A) Typical analysis results of obtained with Linearize DNA control Standard 1 (4×10⁶ copies/µL) to 6 (4×10 copies/µL). (B) The standard curve of the Linearize DNA control 10-fold dilution series. PCR efficiency should be 90-110%. (C) Typical analysis results of obtained with Circular DNA control Standard 1 (2×10⁶ copies/µL) to 5 (2×10² copies/µL). (D) The standard curve of the Circular DNA control 10-fold dilution series. PCR efficiency should be 90-110%.
To evaluate the specificity of assay using Plasmid resDNA Quantitation Kit, no template samples spiked with unrelated DNA were tested. Results shown in the following Table. Unrelated DNA (HEK293, CHO, Vero, Pichia pastoris, and MDCK) were detected in assay, however the values of Mean were outside the range of standard curve (4×106 copies/µL to 4×10 copies/µL).
To evaluate the recovery of assay using Plasmid resDNA Quantitation Kit, three different concentrations of DNA samples were tested. Results shown in the following Table. All samples had recoveries between 80%-110%.
组分（Materials Provided）
| ID | Components | Size |
| OPA-R009-01 | Plasmid Primer & Probe Mix | 550 μL |
| OPA-R009-02 | 2×qPCR Master Mix | 1.6 mL |
| OPA-R009-03 | Circular DNA Control 2×10⁸ copies/μL | 50 μL |
| OPA-R009-04 | Linearize DNA Control 4×10⁸ copies/μL | 50 μL |
| OPA-R009-05 | DNA Dilution Buffer | 1.5 mL×3 |
背景（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.
