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resDetect™ Anti-CD3 Antibody Indirect ELISA Kit (Residue Testing)

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Numéro de produit/spécification
Prix
Qté
RES-A095-96tests
$890.00
ETA of in-stock products:2 business days
Total des articles Montant du produit$ 0

Détails du produit

  • Product Specifications

    Assay Type
    Indirect-ELISA
    Format
    96T (8×12 strips)
    Analyte
    Anti-CD3 Antibody
    Reactivity
    /
    Regulatory Status
    RUO
    Assay Time
    2 hr 20 min
    Sample volume
    100 μL
    Sensitivity
    ≤0.125 ng/mL
    Standard Curve Range
    0.125 ng/mL-4 ng/mL
    Suitable Sample Type
    For the quantitative determination of anti-CD3 antibody in Bioprocess manufacturing applications.

  • Product Overview

    resDetect™ Anti-CD3 Antibody Indirect ELISA Kit (Residue Testing) is based on the Indirect-ELISA method and is used to detect and quantitatively determine anti-CD3 antibody residues in cell therapy products. It is designed to provide a reliable solution for cell therapy product quality assessment during drug development and CMC quality control stages.

  • Reconstitution

    Please see Certificate of Analysis for details of reconstitution instruction and specific concentration.

  • Storage

    1.Store the unopened kit at 2-8°C upon receipt.

    2.Locate the expiration date on the outer packaging and do not use reagents beyond their expiration date.

  • Materials Provided

    ID
    Components
    Size
    RES095-C01
    Pre-coated Human CD3E & CD3G Microplate
    1 plate (8×12 strips)
    RES095-C02
    Anti-CD3 Antibody Standard
    20 μg
    RES095-C03
    HRP-conjugated antibody
    10 μg
    RES095-C04
    10×Washing Buffer
    50 mL
    RES095-C05
    2×Dilution Buffer
    50 mL
    RES095-C06
    Substrate Solution
    12 mL
    RES095-C07
    Stop Solution
    7 mL

  • ACRO Quality Management System

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

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  • Typical Data 

    Please refer to DS document for the assay protocol.

     CD3 TYPICAL DATA

    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.

Validation
  • Dilution Linearity

    To assess the linearity of the assay, samples spiked with high concentrations of Anti-CD3 Antibody were serially diluted with calibrator diluent to produce samples with values within the dynamic range of the assay.

     CD3 DILUTION LINEARITY
  • Intra-Assay Statistics

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

     CD3 INTRA-ASSAY STATISTICS
  • Inter-Assay Statistics

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

     CD3 INTER-ASSAY STATISTICS
  • Recovery

    Five parts of blank T cell culture supernatant were added with different concentrations of Anti-CD3 Antibody, and the T cell culture supernatant without Anti-CD3 Antibody was used as background to calculate the recovery rate. The range of the recovery rate is 81.3-102.5%, and the average recovery is 89.0%.

     CD3 RECOVERY

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Progrès de frontière

 
Progrès du développement médicamenteux
  • Nom anglais:

    T cell surface glycoprotein CD3

  • Catégorie:

  • Nombre de médicaments répertoriés:

    10 Détails

  • Nombre de médicaments cliniques:

    198 Détails

  • Étape de développement la plus élevée:

    Approved

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