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Product Description
SHENTEK® Residual PG13 DNA Quantitation Kit is designed to quantify residual PG13 host cell DNA in biopharmaceutical samples at different stages (in-process through final product). The kit uses quantitative PCR (qPCR) to provide a rapid, specific and reliable quantitation assay with sensitivity at the femtogram (fg) level. The kit includes a PG13 DNA Control as a reference standard and reagents to prepare standard curves and perform absolute quantitation. For extraction recommendations, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit User Guide. The kit is supplied for research use only and provides reagents sufficient for 100 reactions.
Technical Specifications
| Parameter | Details |
|---|---|
| Intended use | Quantitation of residual PG13 host cell DNA in biopharmaceutical samples (in-process and final products) |
| Detection method | Quantitative PCR (qPCR) using FAM-labeled probe |
| Sensitivity | Sensitive to the femtogram (fg) level (analytical sensitivity stated as fg-level in kit documentation) |
| Standard curve concentrations (pg/μL) | 3000 (ST0 stock) and working standards ST1=300, ST2=30, ST3=3, ST4=0.3, ST5=0.03, ST6=0.003 pg/μL |
| Dynamic range (demonstrated by standards) | Approximately 300 to 0.003 pg/μL (prepared standard series provides >5 orders of magnitude coverage from working standards) |
| Reaction volume | 30 μL total reaction volume (20 μL qPCR mix + 10 μL sample/standard) |
| Per-reaction reagent volumes (qPCR MIX) | qPCR Reaction Buffer 17 μL + PG13 Primer&Probe MIX 3 μL (total 20 μL qPCR MIX per reaction) |
| qPCR thermal cycling | Activation: 95 °C 10:00 (1 cycle); Denaturation: 95 °C 00:15 (40 cycles); Annealing/Extension: 60 °C 01:00 (fluorescence read during this step) |
| Instrument compatibility | SHENTEK-96S, ABI 7500, Roche LightCycler 480 II (and other compatible real-time PCR systems supporting FAM detection and absolute quantitation mode) |
| Analysis settings (recommended) | Manual Ct; Threshold = 0.02 (PG13-DNA detector); Auto baseline; Standard curve (Absolute Quantitation) |
| Acceptance criteria / QC | ERC recovery: 50%–150%; NTC Ct should be ≥35 or undetermined; NCS Ct should be larger than mean Ct of lowest standard (or < QL when QL < lowest standard); verify slope/intercept/R² for standard curve |
| Shelf life / stability | -20 °C storage; kit components stable for up to 24 months (check label expiration date) |
| Kit size / throughput | Reagents for 100 reactions |
Features
- High sensitivity: Analytical sensitivity at the femtogram (fg) level for detection of trace residual PG13 DNA.
- Absolute quantitation: Includes PG13 DNA Control and a serial dilution standard curve to perform absolute quantitation (standard curve method).
- Ready-to-use qPCR reagents: qPCR Reaction Buffer and PG13 Primer & Probe mix provided for streamlined plate setup and consistent reactions.
- Validated workflow guidance: Detailed instructions for serial dilutions, controls (ERC, PCS, NCS, NTC), qPCR mix preparation and recommended analysis parameters.
- Compatibility: Compatible with common real-time PCR instruments (e.g., SHENTEK-96S, ABI 7500, LightCycler 480 II).
- Research use supply: Supplied for Research Use Only (RUO) and includes reagents sufficient for 100 reactions.
Applications
- Quantitation of residual PG13 host cell DNA in biopharmaceutical process intermediates
- Quantitation of residual PG13 DNA in final drug substance and drug product
- Method development and validation for host cell DNA assays targeting PG13 cell line
- In-process quality control monitoring of host cell DNA removal
Kit Contents
PG13 DNA Control (NNA049) 50 μL × 1 tube-20 °C
qPCR Reaction Buffer (NNB001) 850 μL × 2 tubes-20 °C, protect from light
PG13 Primer & Probe MIX (NNC101) 300 μL × 1 tube-20 °C
DNA Dilution Buffer (DDB) (NND001) 1.5 mL × 3 tubes-20 °C (store unused DDB at 2–8 °C for working use as directed)
* Total: 100 Reactions | Method: qPCR
Attention
• For Research Use Only (RUO). Not for diagnostic or clinical use.
• Read Material Safety Data Sheets (MSDS) and follow handling and disposal instructions.
• Wear appropriate PPE (protective eyewear, mask, lab coat, gloves).
• Prevent nucleic acid contamination: irradiate workspace, pipettes and tubes with UV for 30 minutes and disinfect with 75% ethanol prior to setup.
• Thaw reagents at 2–8 °C or on ice; vortex and briefly centrifuge before use.
• Prepare standards and controls carefully; include at least five concentrations in the standard curve.
• Seal plates properly, mix and centrifuge briefly before running the qPCR.
• Follow recommended analysis settings (Manual Ct, Threshold 0.02, Auto Baseline) or validate settings per instrument/software.
• QC acceptance: ERC recovery 50%–150%; NTC should be ≥35 cycles or undetermined; NCS Ct must be higher than the lowest standard Ct (or meet QL criteria).
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 detection method used by this kit?
The kit uses quantitative PCR (qPCR) with a FAM-labeled probe for absolute quantitation using a standard curve.
Q2: What sensitivity can I expect from the assay?
The kit documentation reports sensitivity at the femtogram (fg) level. Working standard series are provided down to 0.003 pg/μL (3 fg/μL), but laboratories should validate the limit of quantitation (QL) in their own workflow.
Q3: How should samples and reagents be prepared and loaded?
Prepare qPCR MIX (17 μL qPCR Reaction Buffer + 3 μL Primer&Probe MIX per reaction), aliquot 20 μL per well and add 10 μL of sample or standard (total 30 μL reaction). Include NTC, NCS, PCS and ERC controls and run standards in triplicate. Seal plate, mix and centrifuge briefly before starting the run.
Q4: What are the acceptance criteria for controls?
ERC recovery should be between 50% and 150%. NTC should be ≥35 cycles or undetermined. NCS Ct should be larger than the mean Ct of the lowest standard or meet QL criteria determined in 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.
