project background
CHO Residual DNA Detection Kit
In the field of biopharmaceuticals, CHO cells (Chinese hamster ovarian cells) can be regarded as a brilliant star.
With numerous advantages such as stable expression of exogenous proteins, excellent transfection efficiency, and post-translational modification capabilities of proteins close to those of mammalian cells, it plays a crucial role in the production of biological products such as monoclonal antibodies and recombinant protein drugs, with an application share exceeding 70%.
However, even with extremely strict purification processes adopted in the production of biological products, it is still difficult to avoid the presence of CHO residual DNA. Residual DNA may trigger a series of potential safety risks, such as tumorigenicity, infectivity and immunogenicity issues, just like a "time bomb" hidden in biological products, seriously threatening the safety and quality controllability of the products.
Quality and safety analysis of Biological products
Regulatory requirements
The World Health Organization (WHO) and drug registration regulatory authorities of various countries have successively established strict monitoring and control requirements for exogenous host DNA residues in biological products.
The current guidelines of the U.S. Food and Drug Administration (FDA) recommend that the residual DNA in finished products should not exceed 10ng per dose, and for biological products, the upper limit of host cell DNA residue is 100pg per dose. The General Rules of the European Pharmacopoeia stipulate that the residual DNA limit of biological products is mostly no more than 10ng per dose.
The 2020 Edition of the Chinese Pharmacopoeia, Part III, also clearly states that the residual amount of exogenous host cell DNA in biological preparations produced from cell matrices should not exceed 100pg per dose, and the residual amount of DNA in recombinant hepatitis B vaccines produced from CHO cells should not exceed 10pg per dose.
Product
Advantage
The Baorui Biotech CHO Residual DNA Detection Kit employs the PCR-fluorescence probe method. It designs primer probes targeting the conserved sequences of CHO cells, enabling quantitative detection of CHO residual DNA in samples. The kit contains exogenous internal standards, which can participate in extraction and amplification together with the sample to monitor whether the extraction and amplification are abnormal and improve the quality of the test. The kit adopts the UDG enzyme anti-contamination system, which can effectively prevent or reduce the contamination of amplification products.
1. The reagent has excellent performance.
The detection limit reaches 0.125 fg/μL, and the quantification limit is 0.5 fg/μL.
2. Repeatability (intra-analytical precision), intermediate precision (between instruments, days, personnel, and reagent batches), quantification limit CV≤20%, medium and high concentration CV≤15%.
2. Strong specificity
Seven types of genomes, including SP2/0 cells, Vero cells, Escherichia coli, Salmonella, hybridoma cells, mycoplasma and the human genome, do not interfere with this kit.
3. Convenient and fast operation
1. Single-tube qPCR MIX, convenient to access, no need to prepare the reagent when in use.
2. The finished calibration products can be assembled without dilution, which is convenient and fast.
From sample extraction to the completion of the test, it takes less than 2 hours.
4. Anti-pollution design
The UDG enzyme anti-contamination system can effectively prevent or reduce the contamination of amplification products.
5. Durability
Freeze-thaw stability: The performance of the reagent remains unaffected after being repeatedly freeze-thawed 10 times.
2. Instrument applicability: The performance is not affected on different models of equipment such as ABI 7500, ABl QuantStudio™ 5, Bio-Rad CFX96, SLAN-96P, SLAN-96S, and Roche Light cycler 480 Ⅱ.
References
"Chinese Pharmacopoeia"
2. "Method for Determination of Residual Exogenous DNA"
3. Application and Research of CHO Cell Expression System
4. Detection of CHO Cell DNA Residue in Monoclonal Antibody Products by Magnetic Bead Separation Combined with Quantitative PCR
Product Information
Product Name
CHO Residual DNA Detection Kit (PCR-Fluorescence Probe Method)
Product item Number
BP-QN06-100、BP-QN88-100
Product consultation
0756-8699969
Address: No. 88, Shuian 1st Road, Nanping Science and Technology Park, Xiangzhou District, Zhuhai City, Guangdong Province
Email: marketing@biori.com
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