Residual Pichia pastoris DNA Quantitation Kit SHENTEK™

For Research Use Only (RUO)

$1,545.00

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Sku: SK030205P100
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⚡ Detection Method
qPCR
🕒 Assay Time
Refer to manual
🎯 Storage Temperature
-20 °C (stable for 24 months)

Product Description

SHENTEK® Residual Pichia Pastoris DNA Quantitation Kit is a fluorescence-based quantitative PCR (FAM) assay designed to quantify residual Pichia pastoris host-cell DNA in biopharmaceutical materials across process stages (from in-process samples to final products). The kit includes a Pichia Pastoris DNA Control as a reference standard and provides rapid, specific quantitation with reliable sensitivity at the fg level. The kit workflow supports DNA sample dilution/standard curve preparation, qPCR reaction mix setup and absolute quantitation using a standard curve. Compatible with common real-time PCR instruments (e.g., SHENTEK-96S, ABI 7500, CFX96, StepOne Plus). For DNA extraction guidance, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit User Guide (Product No. 1104191).

Technical Specifications

Parameter Details
Intended use Quantitation of residual Pichia pastoris DNA in biopharmaceutical samples (in-process and final products).
Total reactions per kit Reagents for 100 reactions
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
Reported quantitative range (from supplied standards) 0.03 – 300 pg/µL (equivalent to ~30 fg – 300 pg/µL)
Sensitivity / LOD Reliable quantitation reported at the fg level; lowest supplied standard 0.03 pg/µL (30 fg/µL)
Reaction volume Total reaction volume: 30 µL (qPCR mix 20 µL + sample 10 µL)
qPCR mix composition (per reaction) Pichia Pastoris qPCR Reaction Buffer 17 µL + Pichia Pastoris Primer&Probe MIX 3 µL -> 20 µL qPCR mix
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)
Detection chemistry / dyes Probe-based qPCR with FAM reporter dye (no quencher specified in kit instructions); use ROX as passive reference dye where applicable
Instrument compatibility ABI 7500, CFX96, StepOne Plus, Linegene 9600plus, SHENTEK-96S and similar real-time PCR systems
Ct / analysis settings Manual Ct with Threshold = 0.02; Automatic baseline recommended. NTC Ct should be ≥ 35 cycles (or per internal validation). NCS Ct should be larger than mean Ct of lowest standard.
Spike recovery acceptance Spiked ERC recoveries required to be within 50% - 150%
Shelf life / storage Kit components stored at -20 °C; kit stability up to 24 months (check label expiration date)
Sample input Example workflow uses 100 µL test sample for preparation and 10 µL purified sample per qPCR reaction

Features

  • High sensitivity: Provides reliable quantitation at the fg level (lowest supplied standard 0.03 pg/µL = 30 fg/µL).
  • Probe-based specific detection: FAM-labeled probe assay offers high specificity for Pichia pastoris DNA fragments.
  • Complete standard control: Includes Pichia Pastoris DNA Control for absolute quantitation and serial dilution standard curve.
  • Pre-formulated mix: Supplied reaction buffer and primer/probe mix simplify qPCR setup and reduce preparation time.
  • Wide instrument compatibility: Validated with common real-time PCR platforms (ABI 7500, CFX96, StepOne Plus, Linegene, SHENTEK-96S).
  • Workflow-ready for QC: Designed for in-process and final product host-cell DNA monitoring with recommended plate layouts and analysis settings.

Applications

  • Quantitation of residual Pichia pastoris host-cell DNA in biopharmaceutical process samples
  • In-process testing and final product quality control for recombinant proteins produced in Pichia pastoris
  • Routine host-cell DNA monitoring during downstream purification and formulation
  • Method validation and spike-recovery experiments for DNA residual assays

Kit Contents

Pichia Pastoris DNA Control (Part No. NNA007) 50 µL × 1 tube-20 °C
Pichia Pastoris qPCR Reaction Buffer (Part No. NNB005) 850 µL × 2 tubes-20 °C, protect from light
Pichia Pastoris Primer & Probe MIX (Part No. NNC041) 300 µL × 1 tube-20 °C
DNA Dilution Buffer (DDB) (Part No. NND001) 1.5 mL × 3 tubes-20 °C (note: thaw/mix at 2–8 °C for use; unused DDB may be stored at 2–8 °C per instructions)
* 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, clothing and gloves.

• Prevent nucleic acid contamination: UV-irradiate tabletop, pipettes and tubes for 30 minutes and disinfect with 75% alcohol before setup.

• Protect light-sensitive reagents from light; handle primer/probe and buffers on ice where recommended.

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

• Check kit expiration date and storage conditions on labels prior to use.

• Maintain recommended plate layout, replicate strategy and include NTC, NCS and ERC controls.

• Spike recovery acceptance criteria: 50%–150%.

• NTC Ct should be ≥ 35 cycles (or defined by internal validation).

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 this kit can reliably detect?
The kit supports reliable quantitation at the fg level. The supplied standard curve includes a lowest standard of 0.03 pg/µL (30 fg/µL). Actual LOD in a given matrix should be confirmed by in-house validation.
Q2: How should I prepare the standard curve?
Thaw the Pichia Pastoris DNA Control and DNA Dilution Buffer (DDB) on ice. Prepare ST0 at 3000 pg/µL then perform serial 1:10 dilutions to produce ST1–ST5: 300, 30, 3, 0.3 and 0.03 pg/µL. Include at least five concentrations for the standard curve and run in triplicate.
Q3: What are the recommended qPCR cycling conditions?
Use 95 °C for 10:00 (activation, 1 cycle), then 40 cycles of 95 °C for 00:15 (denaturation) and 60 °C for 01:00 (annealing/extension, fluorescence read). Adjust settings if required by your instrument/software.
Q4: How should reagents be stored after thawing?
Store kit components at -20 °C per label. DNA Dilution Buffer (DDB) may be kept at 2–8 °C for short-term use; follow the instructions regarding storage of unused DDB and inspect for cloudiness/precipitate before use.

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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