Residual Saccharomyces¬†cerevisiae DNA Quantitation Kit SHENTEK®

For Research Use Only (RUO)

$2,575.00

FREE
SHIPPING

100% MONEY
BACK GUARANTEE

ONLINE
SUPPORT 24/7

Sku: 1101103
Tags:
Bulk Quotation Request
⚡ Detection Method
qPCR
🕒 Assay Time
Refer to manual
🎯 Storage Temperature
-20 °C (stable for 24 months)

Product Description

SHENTEK® Residual Saccharomyces cerevisiae DNA Quantitation Kit is designed to quantify residual Saccharomyces cerevisiae DNA in biopharmaceutical materials across process stages from in-process samples to final products. The kit utilizes fluorescent quantitative PCR (qPCR) to provide a rapid, specific and reliable quantitation assay with analytical sensitivity at the femtogram (fg) level. For DNA extraction guidance, refer to SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Product No. 1104191). The kit supplies reagents for 100 reactions and is compatible with common real-time PCR instruments (e.g., SHENTEK-96S, ABI 7500, CFX96, LineGene 9600 plus, Mx3000PTM, StepOne Plus).

Technical Specifications

Parameter Details
Intended use Quantitation of residual Saccharomyces cerevisiae DNA in biopharmaceutical samples (in-process and final products)
Analytical method Fluorescent quantitative PCR (absolute quantitation, standard curve)
Working standard range Serial standards prepared from DNA control: 300 pg/µL, 30 pg/µL, 3 pg/µL, 0.3 pg/µL, 0.03 pg/µL
Lowest standard (example) 0.03 pg/µL (30 fg/µL) included as lowest standard
Analytical sensitivity (LOD) Sensitive to femtogram (fg) level (document states fg-level sensitivity); practical detection guided by lowest standard and lab validation
Limit of quantification (LOQ) Not explicitly specified; users should determine LOQ by laboratory validation. The lowest provided standard is 0.03 pg/µL (30 fg/µL).
Reaction volumes qPCR master mix per reaction 20 µL + 10 µL sample = 30 µL total reaction volume
Master mix composition (per reaction) Saccharomyces cerevisiae qPCR Reaction Buffer 17 µL + Primer & Probe MIX 3 µL (total 20 µL)
Thermal cycling program Activation: 95 °C 10:00 (1 cycle); Denature: 95 °C 00:15 (40 cycles); Anneal/Extend: 60 °C 01:00 (fluorescence read during this step)
Detection dye / probe Reporter: FAM; no quencher specified in instructions (primer & probe mix provided)
Ct threshold / analysis settings Recommended Manual Ct threshold = 0.02; baseline = Automatic. NTC Ct should be ≥ 35.00 cycles or undetermined (or laboratory-specific criteria).
Controls and acceptance criteria Includes DNA control for standard curve, Negative Control Sample (NCS), No Template Control (NTC) and Extraction Reference Control (ERC). ERC recovery acceptance: 50%–150%. Ct(NCS) should be larger than mean Ct of lowest standard (or below LOQ if LOQ proven lower).
Replicates Triplicate measurements recommended for standards, samples and controls
Provided kit size Reagents for 100 reactions
Shelf life / stability Kit components stable for up to 24 months when stored appropriately (see component-level storage)
Recommended consumables DNase-free low-retention tubes and tips; 96-well qPCR plates with sealing film or 8-strip PCR tubes with caps

Features

  • High sensitivity: Designed to detect Saccharomyces cerevisiae DNA down to the femtogram (fg) level; includes low-concentration standards (down to 0.03 pg/µL).
  • Specific and reliable: Contains optimized primer & probe mix and qPCR reaction buffer for specific amplification and reproducible quantitation.
  • Ready-to-use components: Supplies DNA control, qPCR reaction buffer and primer & probe mix to simplify assay setup.
  • Compatible with common qPCR instruments: Validated for use on multiple real-time PCR systems (e.g., SHENTEK-96S, ABI 7500, CFX96, LineGene 9600 plus, Mx3000PTM, StepOne Plus).
  • Long shelf life: Kit components are stable for up to 24 months when stored under recommended conditions.

Applications

  • Quantitation of residual Saccharomyces cerevisiae DNA in biopharmaceutical in-process samples
  • Quantitation of residual Saccharomyces cerevisiae DNA in final drug substance and drug product
  • Host cell DNA residue testing during upstream/downstream process development and release testing (research use)
  • Method validation and spike/recovery experiments using ERC samples

Kit Contents

Saccharomyces cerevisiae DNA Control (Part No. NNA009) — 50 µL × 1 tube-20 °C
Saccharomyces cerevisiae qPCR Reaction Buffer (Part No. NNB006) — 850 µL × 2 tubes-20 °C, protect from light
Saccharomyces cerevisiae Primer & Probe MIX (Part No. NNC039) — 300 µL × 1 tube-20 °C
DNA Dilution Buffer (DDB) (Part No. NND001) — 1.5 mL × 3 tubes-20 °C (note: remaining unused DDB may be stored at 2–8 °C; if cloudy, warm to 37 °C until clear)
* Total: 100 reactions | Method: qPCR (fluorescent quantitative PCR, absolute quantitation via standard curve)

Attention

• For Research Use Only (RUO). 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, gloves).

• Prevent contamination: irradiate bench, micropipettes and tubes with UV for 30 minutes and disinfect with 75% ethanol prior to setup.

• Use DNase-free, low-retention consumables and change tips frequently.

• Thaw reagents at 2–8 °C or on ice; vortex to mix and briefly centrifuge before use.

• Prepare standards by serial dilution as instructed; include at least five concentrations for the standard curve.

• Triplicate measurements are recommended for standards, samples and controls.

• NTC should have Ct ≥ 35 or be undetermined; if not, investigate contamination.

• ERC recovery should be between 50% and 150%; verify extraction efficiency and assay performance.

• Determine LOQ and assay validation parameters within your laboratory according to regulatory guidance.

Quality Management & Certifications

Quality System

Download QMS

QMS (ISO, GMP)

Download Certificate

Quality Advantages

View Report

Quality Control Process

Download Process

📂 Technical Resources & Downloads

PDF Product Manual ↓ PDF MSDS / SDS ↓

Frequently Asked Questions (FAQ)

Q1: What instruments are compatible with this kit?
The kit is compatible with common real-time PCR systems including SHENTEK-96S, ABI 7500, Bio-Rad CFX96, LineGene 9600 plus, Agilent Mx3000PTM and StepOne Plus. If using other instruments, follow instrument-specific setup and validation.
Q2: What is the lowest standard concentration provided and does it represent the kit LOQ?
The lowest provided standard is 0.03 pg/µL (30 fg/µL). The kit states fg-level sensitivity, but you should determine the limit of quantification (LOQ) for your matrix by laboratory validation; the provided lowest standard can be used as a reference point.
Q3: How should I handle and store unused DNA Dilution Buffer (DDB)?
Store remaining unused DDB at 2–8 °C. If the solution becomes cloudy or precipitated, warm to 37 °C until clear before use.
Q4: What are the acceptance criteria for controls?
NTC should be ≥ 35 cycles or undetermined. Ct of NCS should be larger than the mean Ct of the lowest standard (or below LOQ if the LOQ is proven lower than the lowest standard). 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.

 

Terms and Conditions