In the field of biopharmaceutical production, ensuring product safety is of paramount importance. The GeticoSEQ CHO DNA Residue Quantitative Detection Kit, as a professional and efficient detection tool, is dedicated to accurately determining the residual amount of CHO (Chinese Hamster Ovary) host cell DNA in biopharmaceuticals, thus safeguarding the quality of biopharmaceutical products.
This kit is specifically developed for the intermediate products, semi-finished products, and finished products of various biopharmaceuticals, and is used for the accurate quantitative analysis of residual CHO host cell DNA in them. In recombinant protein expression products, purification intermediates, and final finished products, residual CHO cell DNA may pose potential risks. For instance, during the biopharmaceutical manufacturing process, even after strict purification procedures, biopharmaceuticals produced using CHO cells may still contain trace amounts of CHO cell DNA fragments. If these residual DNA enter the human body, they may trigger inflammatory reactions, pose carcinogenic risks, or interfere with immune regulation, thereby affecting the safety and efficacy of the products. The GeticoSEQ CHO DNA Residue Quantitative Detection Kit enables manufacturing enterprises and research institutions to strictly control product quality and meet the strict regulatory requirements for residual host cell DNA in biopharmaceuticals imposed by various countries and regions.
The kit adopts the advanced TaqMan fluorescent probe method for quantitative detection. Its core principle is to design and synthesize probes that can specifically hybridize with the target gene. The 5' end of the probe is labeled with a fluorescent group, and the 3' end is labeled with a quenching group. Under normal circumstances, the two groups are close in spatial distance, so the fluorescent group cannot emit light due to quenching. During PCR amplification, the primers and the probe bind to the template simultaneously, and the binding position of the probe is between the upstream and downstream primers. When the amplification extends to the probe-binding site, the Taq enzyme uses its 5' exonuclease activity to cleave the 5' end fluorescent molecule from the probe, allowing it to emit light. The number of detected fluorescent molecules is proportional to the number of PCR products. Through the fluorescent intensity in the PCR reaction system, the initial amount of DNA template can be accurately calculated. This method complies with the requirements of the United States Pharmacopeia (USP) General Chapters <509> and <1130>, as well as the Chinese Pharmacopoeia General Chapter <3407>. It is widely used in the detection of residual cell nucleic acids in biopharmaceuticals and exhibits high specificity and sensitivity.
- High Sensitivity: The detection limit of the kit is as low as the femtogram (fg) level, enabling it to accurately identify extremely trace amounts of residual CHO cell DNA. Within the detection range of 3 fg/μl to 300 pg/μl, it can achieve accurate quantitative analysis, meeting the strict requirements for the detection of low-level DNA residues in biopharmaceuticals.
- Strong Specificity: Through strict testing and verification, genomic DNA from HeLa cells and Escherichia coli does not interfere with the detection of residual CHO DNA. The kit only detects CHO host cell DNA and has no cross-reaction with DNA from other species, effectively avoiding false-positive results and ensuring the reliability and accuracy of detection results.
- Excellent Stability: Every link, from raw material selection to production process control, strictly adheres to quality standards. Each component of the kit has stable performance, the experimental results have good repeatability, and good consistency is maintained between different batches, providing a reliable guarantee for long-term and large-scale detection work.
- Easy Operation: The kit is equipped with a detailed operation manual, and the process is reasonably designed. The operation steps from sample processing to final detection result acquisition are simple and clear. Even experimental personnel using it for the first time can quickly get started, effectively improving experimental efficiency and reducing human errors.
- Comprehensive Supporting: It provides CHO DNA quantitative reference materials, which have been traced to national standards, offering a reliable calibration basis for experiments. At the same time, it can be used in conjunction with the magnetic bead-based residual DNA sample pretreatment kit to further optimize the sample processing process and improve the detection effect.
It is suitable for biopharmaceutical enterprises, scientific research institutions, third-party testing laboratories, etc., covering the detection of DNA residues in the R&D and production processes of various biopharmaceuticals such as interferons, interleukins, EPO (Erythropoietin), monoclonal antibodies, diagnostic reagents, and recombinant protein vaccines. Whether it is process optimization in the R&D stage, quality control during the production process, or finished product release testing, this kit can play a key role, helping the biopharmaceutical industry ensure product quality and safety.
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