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Product Description
SHENTEK® Residual BHK DNA Quantitation Kit is designed to quantitate residual BHK host cell DNA in different stages of biopharmaceutical products, from in‑process samples to final products. The kit utilizes fluorescent quantitative PCR (qPCR) to perform a rapid, specific, and reliable quantitation assay at the femtogram (fg) level. The kit includes a BHK DNA Control and reagents for preparing standard curves and performing absolute quantitation. For DNA extraction, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Product No. 1104191).
Technical Specifications
| Parameter | Details |
|---|---|
| Intended use | Quantitation of residual BHK host cell DNA in biopharmaceutical samples (in‑process to final product) |
| Assay format | Absolute quantitation by fluorescent qPCR (standard curve) |
| Sensitivity | Detects at the femtogram (fg) level (laboratory validation recommended) |
| Standard curve range (prepared) | 3000 pg/µL, 300 pg/µL, 30 pg/µL, 3 pg/µL, 0.3 pg/µL, 0.03 pg/µL (ST0–ST5 as prepared per protocol) |
| Recommended reaction volume | 30 µL total reaction volume (20 µL qPCR mix + 10 µL sample/standard) |
| qPCR mix composition (per reaction) | qPCR Reaction Buffer 17 µL + BHK Primer&Probe MIX 3 µL → 20 µL qPCR mix; add 10 µL sample/standard to reach 30 µL total |
| Thermal cycling program | Activation 95 °C 10:00 (1 cycle); Denaturation 95 °C 00:15 (40 cycles); Annealing/Extension 60 °C 1:00 (fluorescence read during this step) |
| Fluorescence settings | Reporter dye: FAM; Passive reference: ROX; Quencher: none (per setup instructions) |
| Controls and acceptance criteria | NTC Ct should be ≥ 35 cycles or undetermined; NCS Ct should be larger than mean Ct of the lowest standard (or larger than LOQ Ct if LOQ is below lowest standard); ERC recovery rate should be between 50% and 150% |
| Stability | Kit components stored at -20 °C; stable up to 24 months (check label expiration date) |
| Provided reaction count | Reagents supplied for 100 reactions (kit format) |
Features
- High sensitivity: Capable of quantitating residual BHK DNA at the femtogram (fg) level when properly validated.
- Absolute quantitation: Includes BHK DNA Control and standard curve workflow for absolute quantitation of target DNA.
- Ready-to-use qPCR reagents: Contains qPCR Reaction Buffer and Primer & Probe MIX optimized for the assay to reduce setup variability.
- Compatible with common instruments: Validated for use on SHENTEK‑96S, ABI 7500, Roche LightCycler 480 II and other real‑time PCR systems (instrument settings may vary).
- Designed for biopharma QC: Intended for testing residual host cell DNA across in‑process samples to final product stages and for assay validation workflows.
Applications
- Quantitation of residual BHK host cell DNA in biopharmaceutical products
- In‑process monitoring of host cell DNA levels
- Final product release testing for residual DNA
- Method validation and assay development for host cell DNA quantitation
- Quality control and stability studies involving host cell DNA measurements
Kit Contents
BHK DNA Control (Part No. NNA029) 50 µL × 1 tube-20 °C
qPCR Reaction Buffer (Part No. NNB001) 850 µL × 2 tubes-20 °C, protect from light
BHK Primer & Probe MIX (Part No. NNC076) 300 µL × 1 tube-20 °C, protect from light
DNA Dilution Buffer (DDB) (Part No. NND001) 1.5 mL × 3 tubes-20 °C
* Total: 100 reactions | Method: qPCR
Attention
• For Research Use Only. Not for diagnostic or therapeutic use.
• Read Material Safety Data Sheets (MSDS) and follow all handling instructions.
• Wear appropriate PPE: protective eyewear, mask, lab coat and gloves.
• Use DNase‑free, low retention consumables and clean work area (UV irradiation and 75% ethanol decontamination recommended).
• Thaw reagents at 2–8 °C or on ice, vortex and briefly spin before use; protect light‑sensitive reagents from light.
• Store kit components at -20 °C and check expiration date on the label.
• If DNA Dilution Buffer (DDB) is cloudy, heat at 37 °C until clear before use.
• Include at least five standard points for the standard curve and perform triplicates for samples and controls where recommended.
• ERC recovery rates should be between 50% and 150%; investigate deviations.
• Set instrument analysis parameters (thresholds, baseline, detector settings) according to instrument/software and laboratory validation.
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 analytical sensitivity of the kit?
The kit is designed to enable quantitation at the femtogram (fg) level. The practical limit of detection (LOD) and limit of quantification (LOQ) should be established by laboratory validation. The provided standard curve includes concentrations down to 0.03 pg/µL (30 fg/µL as prepared).
Q2: What instruments are compatible with this kit?
The kit is compatible with common real‑time PCR instruments. The user guide provides example settings for SHENTEK‑96S, ABI 7500 (SDS v1.4), and Roche LightCycler 480 II. Adjust instrument and software parameters as needed for other platforms and validate performance.
Q3: How should I prepare the standard curve?
Thaw the BHK DNA Control and DNA Dilution Buffer at 2–8 °C, dilute the control to 3000 pg/µL (ST0), then perform serial 1:10 dilutions to generate ST1–ST5 (300, 30, 3, 0.3, 0.03 pg/µL). Include at least five concentration points and run standards in triplicate.
Q4: What should I do if the NTC or NCS show amplification?
If NTC shows amplification (Ct < 35), verify reagent and plate handling to identify contamination sources, replace consumables, re‑prepare reagents, decontaminate work surfaces and equipment (UV/ethanol), and repeat the assay. If NCS Ct is not larger than the lowest standard Ct or LOQ Ct, review extraction and dilution procedures and revalidate the LOQ.
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.
