tyc122ccvip

resDetect™ Pichia pastoris resDNA Quantitation Kit (qPCR)

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OPA-R017-100tests
¥14345.00
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tyc122ccvip详情

  • tyc122ccvip概述(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.

  • tyc122ccvip特性(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.
  • 应用说明(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.

  • 技术参数(Technical Specifications)

    DNA 技术参数
  • 使用提示(Attention)

    If your experimental workflow involves host cell DNA sample preparation, please use the recommended sample preparation kits listed in the table. This ensures that the buffers used during both sample preparation and residual DNA quantitation remain consistent, supporting reliable and accurate results.

    DNA 使用提示
  • 组分(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
  • 质量管理控制体系(QMS)

    1. 质量管理体系(ISO, GMP)
    2. 质量优势
    3. 质控流程

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数据展示

  • 典型数据-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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