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Residual DNA Quantification Kit- CHO

Cat.No. :  RDQK-03

Method: qPCR

Size: $1,880.00 / 50 Reactions
$3,250.00 / 100 Reactions

Price: Inquire

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Cat.No.
RDQK-03
Description
This kit is designed and validated for detection of residual CHO DNA in biopharmaceutical products (therapeutic proteins, vaccines, etc.) as required by regulatory agencies. Residual DNA Quantification Kit-CHO is designed based on real-time qPCR technology enables highly sensitive quantitation of residual CHO DNA fast and reliable.
Applications
  • Confirm the rationality of the purification process
  • Ensure quality and safety of the final biopharmaceutical products
  • Features
  • User-Friendly Operation: When used in conjunction with Creative Biogene's Sample preparation kits, it is easy to get the result as less as 5 hours.
  • High Sensitivity: With a quantitation limit as low to pg/μL, the kit meets practical detection requirements.
  • Stable Performance: The kit demonstrates consistent performance across repeated experiments, meeting precision standards.
  • Quality Control: The kit undergoes comprehensive performance validation according to the guidance of pharmacopeia and regulatory.
  • Quality Assurance
  • ISO9001 QMS: The quality management system adheres to ISO9001 standards, ensuring robust processes from R&D to production and quality inspection.
  • Sample Type
    DNA
    Storage
    Store at -20°C.
    Size
    50 Reactions, 100 Reactions
    • Performance Data

    Linearity Range: 30.00-3.00x105 fg/μl

    LOD: 10.00 fg/μl

    LOQ: 30.00 fg/μl

    Precision: CV≤15%

    • Standard Curve

    Quick Inquiry

    Background

    Publications

    Q & A

    Customer Reviews

    Chinese Hamster Ovary (CHO) cells are a cell line that were originally isolated from the ovaries of the Chinese hamster Cricetulus griseus in the 1950s. CHO cells are particularly well suited for the production of recombinant proteins and therapeutic antibodies. Their eukaryotic nature enables them to properly fold and post-translationally modify complex proteins, which is critical for the production of biologically active and effective therapeutics. CHO cells have been extensively optimized and various isoforms and derivatives have been created, such as CHO-K1, CHO-S, and DG44, each with unique properties that benefit different research and production purposes. While CHO cells have provided significant advances and benefits, their use has raised concerns, particularly regarding the presence of residual host cell DNA in the final product. High levels of residual DNA can pose potential risks, including carcinogenicity and immunogenicity. Regulatory agencies around the world, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established strict guidelines regarding acceptable levels of residual DNA. Therefore, ensuring that DNA is removed or reduced to acceptable levels is critical to the production of safe biopharmaceuticals. The Residual DNA Quantification Kit - CHO is specifically designed to meet the need for accurate, sensitive, and reliable quantification of residual DNA in CHO cells.
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    Customer Reviews
    Effectively monitor and control the presence of residual DNA

    By implementing this Residual DNA Quantification Kit as part of routine testing protocols, we can effectively monitor and control the presence of residual DNA throughout the production process. I like it very much.

    United States

    02/23/2023

    Highly Accurate Results

    We've been using the Residual DNA Quantification Kit-CHO in our lab for several months, and the accuracy of the results is exceptional. The kit reliably detects even the smallest amounts of residual DNA, ensuring that our biopharmaceutical products meet stringent quality standards

    United States

    09/24/2023

    Time-Saving

    I appreciate how user-friendly this kit is. The protocol is straightforward and easy to follow. It has significantly reduced the time we spend on residual DNA analysis, allowing us to focus on more critical tasks.

    Germany

    10/13/2021

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