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Product Description
SHENTEK® Residual Vero DNA Quantitation Kit is designed for quantitative measurement of residual Vero host cell DNA in biopharmaceutical samples across processing stages, from in‑process samples to final products. The kit uses quantitative PCR (qPCR) with a Vero-specific primer & probe mix to deliver rapid, specific and reliable quantitation down to the femtogram (fg) level. For DNA extraction, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Product No. 1104191). The kit provides reagents sufficient for 100 reactions and is compatible with common real-time PCR instruments (e.g., SHENTEK-96S, ABI 7500, Bio-Rad CFX96, LineGene 9600).
Technical Specifications
| Parameter | Details |
|---|---|
| Intended use | Quantitation of residual Vero host cell DNA in biopharmaceutical products (in-process and final products) |
| Kit size / Total reactions | Reagents for 100 reactions |
| Analytical method | Absolute quantitation by qPCR (Standard curve / Absolute Quantitation) |
| Sensitivity | Quantitation at the femtogram (fg) level (document states femtogram-level sensitivity) |
| Standard curve concentrations | ST0 (3000 pg/µL prepared stock); ST1 300 pg/µL; ST2 30 pg/µL; ST3 3 pg/µL; ST4 0.3 pg/µL; ST5 0.03 pg/µL; ST6 0.003 pg/µL |
| Reaction volumes | qPCR MIX per reaction: 20 µL; Sample/Standard/NTC/NCS addition: 10 µL; Total reaction volume: 30 µL |
| qPCR mix composition (per reaction) | qPCR Reaction Buffer 17 µL + Vero Primer&Probe MIX 3 µL = 20 µL qPCR MIX per reaction |
| Thermal cycling program | Activation: 95 °C 10:00 (1 cycle); Denaturation: 95 °C 00:15 (40 cycles); Annealing/Extension: 60 °C 01:00 (read fluorescence during this step) |
| Detector / Dyes | Reporter dye: FAM; Passive reference: ROX; Quencher: (none specified) |
| Analysis settings / threshold | Manual Ct selected; Threshold for Vero-DNA set to 0.02; Automatic baseline recommended |
| Acceptance criteria / controls | NTC Ct should be ≥ 35 cycles or undetermined; NCS Ct should be larger than mean Ct of the lowest standard; ERC recovery acceptance: 50%–150% |
| Cycles | 40 cycles |
| Compatible instruments (examples) | SHENTEK-96S, ABI 7500, Bio-Rad CFX96, LineGene 9600 (other real-time PCR systems likely compatible after instrument-specific setup) |
| Storage stability | Kit components can be stored under recommended conditions for up to 24 months (check label expiration date) |
Features
- High sensitivity: Designed for quantitation down to the femtogram (fg) level for detection of trace residual Vero DNA.
- Ready-to-use qPCR reagents: Includes qPCR Reaction Buffer and Vero-specific Primer & Probe MIX to simplify setup and standardization.
- Predefined standard curve: Provided Vero DNA Control and recommended serial dilutions (ST1–ST6) for absolute quantitation and standard curve construction.
- Instrument compatibility: Validated workflows and example instrument settings provided for common real-time PCR systems; parameters can be adjusted per instrument/software.
- Control strategy and QC guidance: Includes instructions for NTC, NCS, and Extraction Reference Control (ERC) with recovery acceptance criteria (50%–150%).
Applications
- Quantitation of residual Vero host cell DNA in biopharmaceutical drug substance and drug product
- In-process testing during biologics manufacturing
- Quality control and release testing for products produced in Vero cell lines
- Method validation and routine monitoring of host cell DNA levels
Kit Contents
Vero DNA Control (NNA010)-20 °C (50 µL × 1 tube)
qPCR Reaction Buffer (NNB001)-20 °C (850 µL × 2 tubes); protect from light
Vero Primer & Probe MIX (NNC016)-20 °C (300 µL × 1 tube)
DNA Dilution Buffer (DDB) (NND001)-20 °C (1.5 mL × 3 tubes)
* Total: 100 Reactions | Method: qPCR
Attention
• For Research Use Only (RUO). Not for use in diagnostic procedures.
• Read Material Safety Data Sheets (MSDS) and follow handling instructions.
• Wear appropriate PPE (protective eyewear, mask, clothing and gloves).
• Use DNase-free, low-retention consumables and maintain a DNA-free workspace (UV decontamination and 75% ethanol recommended).
• Thaw kit components at 2–8 °C or on ice, vortex and briefly centrifuge before use.
• Protect qPCR Reaction Buffer from light during storage and handling.
• Prepare and run at least five concentrations on the standard curve; include NTC, NCS and ERC controls as instructed.
• NTC should be ≥ 35 cycles or undetermined; ERC recovery should be between 50% and 150%; NCS Ct must be greater than mean Ct of lowest standard or less than validated LOQ if LOQ < lowest standard.
• Configure instrument-specific analysis parameters according to your instrument/software version.
Quality Management & Certifications
Quality System
Download QMSQMS (ISO, GMP)
Download CertificateQuality Advantages
View ReportQuality Control Process
Download ProcessTechnical Resources & Downloads
Frequently Asked Questions (FAQ)
Q1: What is the kit sensitivity (LOD/LOQ)?
The kit is intended to quantify residual Vero DNA down to the femtogram (fg) level. The validated limit of quantitation (LOQ) should be determined by laboratory validation; if LOQ is below the lowest standard, ensure NCS Ct is less than the LOQ concentration.
Q2: How many reactions are provided per kit?
The kit provides reagents sufficient for 100 reactions.
Q3: What are the recommended storage conditions?
Store kit components at -20 °C. The components are stable for up to 24 months; check individual tube labels for expiration.
Q4: Which qPCR instruments are compatible?
The kit is compatible with common real-time PCR systems. The user guide provides example settings for SHENTEK-96S, ABI 7500, Bio-Rad CFX96 and LineGene 9600. For other instruments, follow instrument-specific setup and validation.
Research Use Only
✔
Research Use Only (RUO) – This product is intended for laboratory research purposes only and not for clinical or regulatory diagnostic use.
✔
Not intended for use in USDA or FDA regulated diagnostic testing or official compliance testing.
When can I expect my order to ship?
Most orders are filled and shipped within 2-3 business days from the time they are received.
Our standard shipping usually take 2-5 days.
We also provide express shippping for time-sensitive deliveries.
Email contact@biofargo.com if you have any requirements.
