Residual NS0 & SP2/0 DNA Quantitation Kit SHENTEK®

For Research Use Only (RUO)

$1,545.00

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Sku: SK030208N100
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⚡ Detection Method
qPCR
🕒 Assay Time
Refer to manual
🎯 Storage Temperature
-20 °C (stable for 24 months)

Product Description

SHENTEK® Residual NS0&SP2/0 DNA Quantitation Kit is a qPCR-based assay for quantitation of residual NS0 and SP2/0 host cell DNA in biopharmaceutical matrices (in-process samples to final products). The kit provides NS0&SP2/0 DNA Control as a reference standard and contains qPCR Reaction Buffer, NS0&SP2/0 Primer & Probe MIX, and DNA Dilution Buffer. The assay is designed for sensitive, specific and rapid quantitation at the femtogram (fg) level. Reagents in this kit are sufficient for 100 reactions. For DNA extraction procedures refer to SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Product No. 1104191). For Research Use Only (RUO).

Technical Specifications

Parameter Details
Intended use Quantitation of residual NS0 and SP2/0 host cell DNA in biopharmaceutical products (in-process and final products)
Assay format Absolute quantitation by qPCR using a supplied standard curve
Sensitivity Designed to quantitate at femtogram (fg) level; lowest kit standard = 0.003 pg/µL (3 fg/µL). Laboratory validation required to establish LOD/LOQ.
Standard curve concentrations 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 (ST0 stock: 3000 pg/µL)
Reaction volume 30 µL total reaction volume (20 µL qPCR mix + 10 µL sample or control)
qPCR mix per reaction qPCR Reaction Buffer 17 µL + NS0&SP2/0 Primer & Probe MIX 3 µL = 20 µL per reaction
Thermal cycling conditions Activation: 95 °C 10:00 (1 cycle); Denaturation: 95 °C 00:15 (40 cycles); Annealing/Extension: 60 °C 1:00 (data acquisition during this step)
Instrument compatibility Compatible with common real-time PCR instruments (examples: SHENTEK-96S, ABI 7500, Bio-Rad CFX96, StepOne Plus, LineGene 9600, Mx3000P)
Acceptance criteria / QC ERC recovery: 50%–150%; NTC Ct should be ≥ 35 cycles or undetermined (or per lab validation); Ct of NCS should be > mean Ct of lowest standard or below validated LOQ
Stability Kit components stable for up to 24 months when stored as instructed
Reactions per kit Reagents for 100 reactions
Reference / related product For extraction information see SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Product No. 1104191)

Features

  • High sensitivity: Capable of quantitation at femtogram (fg) level; lowest supplied standard 0.003 pg/µL
  • qPCR-based absolute quantitation: Supplies DNA control and primer/probe mix for construction of standard curve and absolute quantitation
  • Ready-to-use reagents: Pre-formulated qPCR Reaction Buffer and Primer & Probe MIX minimize assay setup variability
  • Compatibility: Validated for use on multiple common real-time PCR platforms
  • Quality controls included: Includes NS0&SP2/0 DNA Control for standard curve and guidance for NTC, NCS and ERC controls

Applications

  • Quantitation of residual NS0 host cell DNA in biopharmaceutical process intermediates and final drug substance/formulation
  • Quantitation of residual SP2/0 host cell DNA in biopharmaceutical samples
  • Method development and validation for host cell DNA testing in QC and R&D (Research Use Only)
  • In-process monitoring of DNA clearance during purification workflows

Kit Contents

NS0&SP2/0 DNA Control (Part No. NNA021)-20 °C; 50 µL × 1 tube
qPCR Reaction Buffer (Part No. NNB001)-20 °C; 850 µL × 2 tubes; protect from light
NS0&SP2/0 Primer & Probe MIX (Part No. NNC029)-20 °C; 300 µL × 1 tube
DNA Dilution Buffer (DDB) (Part No. NND001)-20 °C; 1.5 mL × 3 tubes (remaining unused DDB store 2–8 °C; if cloudy, heat to 37 °C until clear)
* Total: 100 reactions | Method: qPCR

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, laboratory clothing and gloves

• Use DNase-free, low-retention consumables and dedicated workspace

• Decontaminate workspace, pipettes and tubes with UV for 30 minutes and 75% ethanol before setup

• Thaw reagents at 2–8 °C or on ice, vortex and spin briefly prior to use

• Protect qPCR Reaction Buffer from light

• Seal plates/strips and spin briefly before running qPCR

• Establish laboratory-specific LOQ/LOD by validation; NTC Ct acceptance: ≥ 35 cycles or undetermined

• ERC recovery acceptance: 50%–150%

Quality Management & Certifications

Quality System

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QMS (ISO, GMP)

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Quality Advantages

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Quality Control Process

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📂 Technical Resources & Downloads

PDF Product Manual ↓ PDF MSDS / SDS ↓

Frequently Asked Questions (FAQ)

Q1: What is the lowest concentration standard provided in the kit and what sensitivity can I expect?
The lowest supplied standard (ST6) is 0.003 pg/µL (3 fg/µL). The kit is designed to enable quantitation at the femtogram level; however, actual limit of detection (LOD) and limit of quantitation (LOQ) should be established by laboratory validation.
Q2: How should I prepare the standard curve?
Thaw the NS0&SP2/0 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 prepare ST1–ST6 (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). Include at least five concentrations on the standard curve for quantitation.
Q3: What qPCR cycling conditions and reaction setup should I use?
Use a 30 µL reaction volume (20 µL qPCR mix + 10 µL sample). Cycling: Activation 95 °C for 10:00 (1 cycle); Denaturation 95 °C for 0:15 (40 cycles); Annealing/Extension 60 °C for 1:00 with fluorescence read during this step. Prepare qPCR mix per reaction: 17 µL qPCR Reaction Buffer + 3 µL Primer & Probe MIX.
Q4: How do I interpret controls and QC criteria?
NTC should be undetermined or have Ct ≥ 35 (or per lab validation). NCS Ct should be larger than mean Ct of lowest standard in the curve or below validated LOQ. ERC recovery should be between 50% and 150%.

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.

 

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