| Field | Specification |
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Description
Plasmid DNA Residue Detection Kit is used for the quantitative analysis and detection of plasmid DNA residues in biological products such as vaccines, gene and cell therapy products. Because viral vectors (e.g. lentiviruses, adenoviruses, etc.) are usually used in the development and production of these biologics, and most of the viral vectors are prepared by transient transfection of plasmid DNA into packaged cell matrices, so in order to ensure the purity and safety of the viral vectors, these plasmid DNAs attached on the surface of viral vectors will be removed as impurities during the viral purification process.
The kit designs specific primers for plasmid DNA sequences used in the market, and adopts the qPCR fluorescent probe principle to detect residual plasmid DNA specifically and rapidly, and its minimum detection limit can reach 1 copies/μL level, and the kit is accompanied by a linear Plasmid DNA Control (plasmid DNA quantitative reference). The kit needs to be used together with the the Residual DNA Sample Preparation Kit (Cat# 18461ES).
Feature
- Compliance with regulations: the products are fully validated according to the requirements of Chp, USP, ICH, etc., and their performance is in line with Chinese and foreign regulations and standards;
- Guarantee of quality: the raw materials of the kits are all self-developed, and the qPCR Mix and other enzyme products are produced in an ultra-clean enzyme factory;
- High sensitivity: the limit of quantification can reach 4 copies/μL level;
- High precision: high intra-batch repeatability and low inter-batch variation;
- Strong exclusivity: specific detection of residual Plasmid DNA without interference from other exogenous genomic DNA;
- Strong anti-interference: add internal control (IC), easy to exclude sample interference, reaction preparation abnormalities and other factors.
Application
Residual Plasmid DNA test in biological products.
Specification
|
Sensitivity |
4 copies/μL (range 4×101copies/μL ~ 4×106copies/μL) |
|
Assay Time |
~1.5 hours |
|
Assay Principle |
Fluorescent probe qPCR method |
|
Required Instruments |
Real-time fluorescence quantitative PCR system |
Components
|
Components No. |
Name |
41323ES50-EN |
41323ES60-EN |
|
41323-A |
Plasmid qPCR Mix |
0.75 mL |
1.5 mL |
|
41323-B |
Plasmid Primer&Probe Mix |
200 μL |
400 μL |
|
41323-C |
DNA Dilution Buffer |
1.8 mL×2 |
1.8 mL×4 |
|
41323-D |
Linear Plasmid DNA Control (4×108 copies/μL) |
25 μL |
50 μL |
|
41323-E |
IC* |
50 μL |
100 μL |
*IC：Internal control.
Storage
This product should be stored at -25~-15℃ for 2 years.
Both 41323-A and 41323-B should be stored protected from light.
Figures
- Limit of quantification
Plasmid DNA was detected at concentrations of 40copies/μL, 10copies/μL, 4 copies/μL, and 1copies/μL, with 10 replicates for each concentration. The results showed that the CV was <20% at concentrations of 4copies/μL and above, i.e., the limit of quantification of the plasmid DNA residue detection kit could reach 4 copies/μL.
|
Test item |
Plasmid DNA (copies/μL) |
|
|
Quantity |
Return ratio |
|
|
1 |
5.33 |
133.15% |
|
2 |
4.14 |
103.45% |
|
3 |
5.54 |
138.44% |
|
4 |
4.47 |
111.77% |
|
5 |
5.85 |
146.27% |
|
6 |
4.94 |
123.59% |
|
7 |
3.63 |
90.85% |
|
8 |
4.3 |
107.49% |
|
9 |
4.1 |
102.39% |
|
10 |
4.37 |
109.19% |
|
Average value |
4.67 |
\ |
|
CV% |
15.33% |
\ |
Table 1. Limit of quantification (LOQ) assay results for Plasmid DNA
Documents:
Host cell DNA (HCD) residue testing is required for biopharmaceutical manufacturing under ICH Q5A, ICH Q6B, FDA 21 CFR Part 610, and EMA guidelines. Acceptable residual HCD limits are typically ≤10 ng/dose (WHO guideline) or ≤100 pg/dose for continuous cell line-derived products, depending on the product class and route of administration. This kit provides qPCR-based quantification traceable to validated reference standards.
This kit uses primers and probes targeting genome-specific repetitive elements (e.g., Alu elements for human HEK293/CHO, LINE-1 for mammalian cells, or species-specific rDNA repeats for yeast/insect cell lines) that are highly conserved and abundant in the host genome. This provides high sensitivity — typically detecting sub-picogram quantities of residual host DNA — without cross-reacting with the target product or plasmid sequences.
Yes. The quantitative qPCR format of this kit is suitable for lot release testing, process characterization, and stability monitoring of biopharmaceutical drug substances and drug products. To generate regulatory-compliant data, assay performance qualification (sensitivity, specificity, linearity, spike recovery) should be documented per applicable guidelines. Contact your QA team to confirm kit suitability for your specific regulatory submission.
The LOD varies by kit generation and target cell line (e.g., HEK293, CHO, E. coli, Pichia pastoris). Third-generation (3G) kits typically achieve LOD values of 0.1–1 pg of host cell DNA per reaction. The validated linear range spans 4–6 orders of magnitude, supporting both low-level process monitoring and high-level spiking experiments. Validated LOD and LOQ values are provided in the product-specific datasheet.
Yeasen Biotechnology offers flexible customization options for many of its assay kits and detection reagents, including custom lot sizes, bulk ordering, and application-specific formulation adjustments. Volume pricing, custom packaging, and kit bundling may be available depending on the product and intended workflow. A Certificate of Analysis (CoA) and lot-specific QC data are provided with every order. For inquiries regarding large-volume orders, custom configurations, or integration into automated workflows, please contact the BioHippo team for a tailored quotation.
