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resDetect™ Pichia pastoris resDNA Quantitation Kit (qPCR)

COADSMS
DS

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Cat. No. / Size
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OPA-R017-100tests
$2385.00
ETA of in-stock products:2 business days
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Product Details

  • Product Overview

    Pichia pastoris resDNA Quantitation Kit is designed for quantitative detection of residual Pichia pastoris DNA in biopharmaceuticals (Antibodies, Vaccines, etc.). Based on real-time quantitative PCR (qPCR) method, this kit makes the detection of the residual DNA from Pichia pastoris rapid and reliable. The lower limit of quantitation is 3 fg/µL. All procedures are typically in less than 4 hours.

    Use the kit after you extract host cell DNA from test samples. To achieve the best performances, resDNA Sample Preparation Kit Ⅱ(Magnetic Beads) (Cat. No. OPA-R024) is recommended for DNA extraction.

  • Features

    1. High sensitivity for optimal product safety: LLOD (1 fg/µL) for detection of residue host cell DNA
    2. High specificity: No cross-reactivity with unrelated DNA
    3. Validation: ICH Q2(R2) as Validation of Analytical Procedures
    4. High-quality: This kit is manufactured in ISO 13485 standard facility.

  • Application

    The kit is used for quantitative detection of residual Pichia pastoris DNA in biopharmaceuticals.

    For use in quality control/manufacturing process only.

    It is for research use only.

  • Technical Specifications

    DNA Technical Specifications

  • Attention

    If your experimental process requires sample preparation, please purchase and conduct the experiment using the sample preparation kits recommended in the table to ensure that the buffers used in both the sample preparation and resDNA detection are consistent.

    DNA Attention

  • Materials Provided

    ID
    Components
    Size
    OPA-R017-01
    2×qPCR Master Mix
    1.0 mL×2
    OPA-R017-02
    Pichia Primer & Probe Mix
    700 μL
    OPA-R017-03
    Pichia DNA Control（3ng/μL）
    100 μL
    OPA-R017-04
    Dilution Buffer
    1.5 mL×3
    OPA-R017-05
    DNase/RNase-Free Water
    1.0 mL

  • ACRO Quality Management System

    1. QMS(ISO, GMP)
    2. Quality Advantages
    3. Quality Control Process

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Performance Data

  • Typical Data 

    Please refer to DS document for the assay protocol.

    DNA TYPICAL DATA

    Figure 1. High sensitivity and broad dynamic range using the Pichia pastoris resDNA Quantitation Kit. (A) Typical analysis results obtained with Standard 1 (300 pg/μL) to 6 (3 fg/μL). (B) The standard curve of the 10-fold dilution series. PCR efficiency should be 90-110%.

  • DNA TYPICAL DATA

    Figure 2. Assay specificity. Standard curves generated using 10-fold serial dilution of Pichia pastoris genomic DNA (included in the kit) in the presence of DNA (CHO, E. coli and HEK293).

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