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Product Description
SHENTEK® Residual MRC-5 DNA Quantitation Kit is a qPCR-based assay for quantitation of residual MRC-5 host cell DNA in biopharmaceutical samples at in-process and final product stages. The kit enables rapid, specific, and reliable absolute quantitation down to the femtogram (fg) level using an included MRC-5 DNA Control as reference standard. The kit is supplied as reagents for 100 reactions (Product No.: 1101124) and is intended for research use only. For sample extraction guidance, refer to the corresponding SHENTEK® Residual Host Cell DNA Sample Preparation Kit User Guide (Product No. 1104191). Compatible with common real-time PCR instruments (e.g., SHENTEK-96S, ABI 7500).
Technical Specifications
| Parameter | Details |
|---|---|
| Intended use | Quantitation of residual MRC-5 host cell DNA in biopharmaceutical samples (in-process and final products) |
| Detection method | Absolute quantitation by qPCR (FAM reporter) |
| Sensitivity / analytical sensitivity | Sensitive to femtogram (fg) level; lowest standard used 0.03 pg/µL (30 fg/µL). |
| Standard curve concentrations | Standard points: ST1 = 300 pg/µL, ST2 = 30 pg/µL, ST3 = 3 pg/µL, ST4 = 0.3 pg/µL, ST5 = 0.03 pg/µL (prepare from ST0 = 3000 pg/µL) |
| NTC acceptance criteria | Detection value of NTC should be ≤ 6.00 fg/µL (or laboratory-specific criteria after method validation) |
| Recovery acceptance (ERC) | ERC sample recovery should be between 50% and 150% |
| Reaction volume | 30 µL total reaction volume (20 µL qPCR mix + 10 µL template/sample) |
| qPCR reaction mix per test | Per reaction: qPCR Reaction Buffer 17 µL + MRC-5 Primer & Probe MIX 3 µL (prepare 20 µL qPCR MIX then add 10 µL sample/control) |
| Thermal cycling conditions | Activation: 95°C 10:00 (1 cycle); Denaturation: 95°C 0:15 (40 cycles); Annealing/extension and read: 60°C 1:00 (40 cycles) |
| Instrument compatibility | SHENTEK-96S Real-Time PCR System, ABI 7500 Real-Time PCR System (SDS v1.4 example provided); compatible with standard real-time PCR instruments |
| Kit format and size | Reagents for 100 reactions; Product No. 1101124; Version A/0 |
| Storage stability | Kit components can be stored under appropriate conditions for up to 24 months (individual components stored at -20 °C as labeled) |
| Result reporting units | Mean Quantity reported in pg/µL (results exportable from instrument software) |
| Quality control / acceptance | NCS Ct should be larger than mean Ct of lowest standard; NTC detection value ≤ 6.00 fg/µL; ERC recovery 50–150% |
Features
- High sensitivity: Quantitation down to the femtogram level (lowest standard 0.03 pg/µL = 30 fg/µL) enabling detection of trace residual host-cell DNA.
- Absolute quantitation: Includes MRC-5 DNA Control for construction of a standard curve and absolute quantitation.
- Ready-to-use qPCR reagents: Pre-formulated qPCR Reaction Buffer and Primer & Probe mix simplify setup and reduce preparation variability.
- Instrument compatibility: Validated workflows and example settings provided for common real-time PCR platforms (ABI 7500, SHENTEK-96S).
- Designed for biopharma QC: Appropriate for in-process and final product testing, and for method validation and routine QC of residual host cell DNA.
Applications
- Quantitation of residual MRC-5 host-cell DNA in biopharmaceutical products
- In-process sample testing during downstream processing
- Final product QC testing for host-cell DNA content
- Method validation and recovery assessment (using ERC samples)
Kit Contents
MRC-5 DNA Control (NNA062) 50 µL × 1 tube-20 °C
qPCR Reaction Buffer (NNB001) 850 µL × 2 tubes-20 °C, protect from light
MRC-5 Primer & Probe MIX (NNC118) 300 µL × 1 tube-20 °C
DNA Dilution Buffer (DDB) (NND001) 1.5 mL × 3 tubes-20 °C (remaining unused DDB store at 2–8 °C after thaw; if cloudy, heat to 37 °C until clear)
* Total: 100 reactions | Method: qPCR
Attention
• For Research Use Only (RUO). Read Material Safety Data Sheets (MSDS) before use.
• Wear appropriate PPE: protective eyewear, mask, lab coat and gloves.
• Prevent contamination: irradiate bench, 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 spin down before use.
• Use RNase/DNase-free consumables and low-retention tips; follow sterile technique.
• Prepare standard curve with at least five concentration points; perform method validation to select sample dilutions.
• Seal plates properly, mix on microplate shaker and briefly centrifuge before running.
• Acceptance criteria: ERC recovery 50–150%; NCS Ct should be larger than the mean Ct of the lowest standard; NTC signal ≤ 6.00 fg/µL (or lab-defined 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 analytical sensitivity (limit of detection) of the kit?
The kit is designed to detect residual MRC-5 DNA at the femtogram (fg) level. The lowest standard provided is 0.03 pg/µL (30 fg/µL). The NTC acceptance criterion is ≤ 6.00 fg/µL; final LOD should be established during method validation.
Q2: How many reactions are supplied in a single kit?
This kit supplies reagents for 100 reactions (Product No. 1101124).
Q3: What instrument settings should I use?
Example settings for ABI 7500 (SDS v1.4) are provided: 30 µL reaction volume; Activation 95°C 10:00; 40 cycles of 95°C 0:15 and 60°C 1:00 with signal read at 60°C. If using other instruments, adapt thermal profile and settings according to the instrument documentation and validate accordingly.
Q4: How should I store kit components and how long are they stable?
Store kit components at -20 °C as labeled. The kit components can be stored under appropriate conditions for up to 24 months. After thawing, store unused DNA Dilution Buffer (DDB) at 2–8 °C; if it becomes cloudy, incubate at 37 °C until clear.
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.
