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For Research Use Only (RUO)
Product Description
SHENTEK® Residual Sf9 DNA Size Analysis Kit is a qPCR-based kit for rapid, specific quantitation and size distribution analysis of residual Sf9 host-cell DNA in biopharmaceutical samples (from in‑process to final products). The assay amplifies four target fragment lengths (87 bp, 118 bp, 225 bp and 500 bp) using FAM-labeled detection and includes an internal positive control (IPC, VIC). The kit achieves sensitivity at the level of femtograms (fg). This package contains reagents to perform 4 × 100 reactions (primer/probe mixes for four fragment sizes, qPCR reaction buffer, Sf9 DNA control, IPC mix and DNA dilution buffer). For DNA extraction/sample preparation refer to SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Product No. 1104191).
Technical Specifications
| Parameter | Details |
|---|---|
| Target fragment sizes | 87 bp, 118 bp, 225 bp, 500 bp |
| Limit of detection (LOD) | Sensitivity at femtogram (fg) level |
| Standard curve concentrations (recommended) | 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 (Note: MIX-87 and MIX-118: ST1–ST6; MIX-225 and MIX-500: ST1–ST5) |
| Reaction volumes | qPCR MIX per well = 20 µL; template/sample = 10 µL; total reaction volume = 30 µL |
| qPCR mix composition (per reaction) | qPCR Reaction Buffer 15.9 µL; Sf9 Primer&Probe MIX (per fragment) 2.8 µL; IPC MIX 1.3 µL; total 20 µL |
| Thermal cycling profile | Activation: 95 °C 10:00 (1 cycle); Denaturation: 95 °C 00:15; Annealing: 60 °C 00:30; Extension: 72 °C 01:30; 40 cycles (instrument reads fluorescence during extension step) |
| Ct and analysis thresholds | Manual Ct threshold = 0.02 (FAM); VIC (IPC) threshold = 0.1; Automatic baseline recommended |
| Controls and acceptance criteria | NTC Ct should be ≥ 35 cycles or undetermined; NCS Ct should be larger than mean Ct of lowest standard and show VIC amplification; sample Ct-IPC should be within ±1.0 Ct of NCS Ct-IPC (IPC used to detect inhibition) |
| Replicates | Recommend triplicates for standards, controls and test samples |
| Compatibility / instruments | Validated on SHENTEK-96S, ABI 7500, and LightCycler 480 II; compatible with other real-time PCR systems (follow instrument-specific setup) |
| Kit stability | Components stable for up to 24 months when stored as indicated on labels |
| Intended use | Quantitative size analysis of residual Sf9 host-cell DNA in biopharmaceutical samples (research applications) |
Features
- Four-size multiplexed analysis (separate assays): Designed to determine size distribution by amplifying four discrete fragment lengths (87, 118, 225, 500 bp) for accurate fragment-size profiling.
- High sensitivity: LOD at the femtogram level enables detection and quantitation of trace residual Sf9 DNA.
- qPCR-based absolute quantitation: Standard-curve (absolute quantitation) workflow with serial dilutions and recommended concentration points for accurate quantification.
- Internal Positive Control (IPC): IPC (VIC channel) included to monitor reaction integrity and identify sample inhibition.
- Ready-to-use primer/probe mixes: Pre-formulated Sf9 Primer & Probe MIXes for each fragment length reduce setup variability and save time.
- Instrument compatibility: Compatible with common real-time PCR platforms (SHENTEK-96S, ABI 7500, LightCycler 480 II); protocol includes instrument-specific guidance.
Applications
- Quantitation of residual Sf9 host-cell DNA in biopharmaceutical in-process samples
- Residual DNA analysis in final biologic drug products derived from Sf9/baculovirus systems
- Size distribution profiling of host-cell DNA fragments (87–500 bp range)
- Method validation and routine QC for host DNA clearance processes (research use)
Kit Contents
Attention
• For Research Use Only (RUO). Not for diagnostic use.
• Read Material Safety Data Sheets (MSDS) and follow handling instructions.
• Wear appropriate PPE: protective eyewear, mask, lab coat, and gloves.
• Decontaminate work surface, pipettes and tubes with UV (30 minutes) and 75% ethanol before experiments.
• Thaw reagents completely at 2–8 °C or on ice; vortex and briefly centrifuge before use.
• Protect light-sensitive reagents (qPCR Reaction Buffer) from light.
• Store kit components at temperatures indicated on labels; kit stable up to 24 months.
• If DNA Dilution Buffer (DDB) is cloudy, heat at 37 °C until clear; store unused DDB at 2–8 °C.
• Prepare separate standard curves for each fragment length; include at least five standard points.
• Run technical replicates (triplicates recommended) and include NTC and NCS controls.
• Interpret IPC Ct: sample mean Ct-IPC should be within ±1.0 of NCS Ct-IPC; higher IPC Ct indicates inhibition.
• NTC should be ≥ 35 cycles or undetermined; if not, investigate contamination.
Quality Management & Certifications
Quality System
Download QMSQMS (ISO, GMP)
Download CertificateQuality Advantages
View ReportQuality Control Process
Download ProcessTechnical Resources & Downloads
Frequently Asked Questions (FAQ)
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.

