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resDetect™ VH3 ELISA Kit (Residue Testing)

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RES-A059-96tests
¥5775.00
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产品详情

  • 产品参数(Product Specifications)

    Assay Type
    Sandwich-ELISA
    Analyte
    VH3 binding Protein A
    Format
    96T(8×12 strips)
    Regulatory Status
    RUO
    Sensitivity
    <50pg/mL
    Standard Curve Range
    50 pg/mL-8100 pg/mL
    Assay Time
    2 hr
    Suitable Sample Type
    For the quantitative determination of recombinant VH3 binding protein A
    Sample volume
    50ul

  • 产品概述(Product Overview)

    resDetect™ VH3 ELISA Kit (Residue Testing) is based on Sandwich-ELISA and is used to measure both natural and recombinant forms of VH3 residues in antibody drug preparations, including structurally distinct variants such as MabSelect™ VH3. It is designed to provide an essential tool for optimal purification process development and routine quality control of in-process streams and final products, ensuring the accurate monitoring of VH3 levels and maintaining product quality.

  • 存储(Storage)

    1. Unopened kit should be stored at 2℃-8℃ upon receiving.

    2. Find the expiration date on the outside packaging and do not use reagents past their expiration date.

    3. The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.

  • 组分(Materials Provided)

    ID
    Components
    Size
    RES059-C01
    Pre-Coated Anti-VH3 Antibody Microplate
    1 plate(8×12 strips)
    RES059-C02
    Recombinant VH3 binding Protein A Standard (1μg/mL)
    100uL
    RES059-C03
    Biotin-Anti-VH3 Antibody
    1.5mL
    RES059-C04
    Streptavidin-HRP
    10ug
    RES059-C05
    10×Sample Dilution Buffer
    15mL
    RES059-C06
    Denaturation Buffer
    15mL
    RES059-C07
    20×Washing Buffer
    30mL
    RES059-C08
    Antibody Dilution Buffer
    15mL
    RES059-C09
    Streptavidin-HRP Dilution Buffer
    15mL
    RES059-C10
    Substrate Solution
    12mL
    RES059-C11
    Stop Solution
    8mL

  • 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

数据展示

  • 典型数据-Typical Data

    Please refer to DS document for the assay protocol.

     VH3 TYPICAL DATA

    Detection of Recombinant VH3 binding Protein A by sandwich-ELISA Assay.
    Immobilized Anti-VH3 binding Protein A Antibody can bind Recombinant VH3 binding Protein A. Detection was performed using Biotin-Anti-VH3 Antibody with sensitivity of 50 pg/mL (QC tested). For each experiment, a standard curve needs to be set for each micro-plate, and the specific OD value may vary depending on different laboratories, testers, or equipments. The following example data is for reference only.

验证
  • 批内差异(Intra-Assay Statistics)

    Three samples of known concentration were tested ten times on one plate to assess intra-assay precision.

     VH3 INTRA-ASSAY STATISTICS
  • 批间差异(Inter-Assay Statistics)

    Three samples of known concentration were tested in three separate assays to assess inter-assay precision.

     VH3 INTER-ASSAY STATISTICS
  • 回收率(Recovery)

    Add different concentrations of VH3 binding Protein A (0.2ng/mL、1ng/mL、10ng/mL) to different concentrations of Human IgG4 (Toripalimab) (20mg/mL、10mg/mL、5mg/mL), then dilute the antibodies to a reasonable range, then test and calculated the concentration of VH3 binding protein A to give the recovery rate.

     VH3 RECOVERY
  • 干扰效应(Interference effect)

    We have conducted interference effect test about frequently-used buffers, they have excellent buffer compatibility. For specific buffers, it is recommended that you verify recovery to determine the minimum dilution ratio.

     VH3 INTERFERENCE EFFECT
  • 专属性(Specificity)

    Host cell protein (HCP 500 ng/mL) and host cell DNA (HCD 0.5 ng/mL) of HEK293, E.coli or CHO systems were added to human IgG1 (Bevacizumab, 1mg/mL) and human IgG4 (Toripalimab, 1mg/mL), respectively, which were higher than the usual quality standard limit. Then high, medium, and low concentrations of VH3 binding Protein A were added, respectively, and the ratio of VH3 binding Protein A recovery in the VH3 binding Protein A added samples without HCP and HCD was added as the specificity verification index. verification index.

     VH3 SPECIFICITY

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