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Biopharmaceutical products, such as therapeutic proteins and vaccines, are produced by fermentation using either bacterial or eukaryotic cells. The cells used to produce biopharmaceuticals can be sources of a range of complex, heterogeneous, and potentially unsafe impurities, and host cell DNA is among these. The residual host cell DNA may result in tumors or adverse reactions. Besides, cells used to produce biopharmaceuticals may possibly carry viruses or harbor harmful nucleic acid, and the residual DNA in a given biopharmaceutical product may be infectious. Therefore, some regulatory agencies have allowed a target of 100 pg or less of residual DNA per dose in biopharmaceuticals, and levels up to 10 ng of residual DNA per dose may be considered, depending on the source of the residual DNA and the product's route.
The analytical methods used to determine the residual DNA content of biopharmaceuticals include hybridization based assay, DNA-binding protein based residual DNA assay, quantitative PCR (q-PCR), or other DNA amplification methods. Among these methods, quantitative PCR (q-PCR) is currently the most commonly used technique to determine the content of residual DNA. Creative Biogene offers a variety of q-PCR based residual DNA quantification kits for your research. All of them are easy to use and high sensitivity that can help you to confirm the rationality of the purification process and ensure quality and safety of the final biopharmaceutical products.
Product Data 1: Residual DNA Quantification Kit-E.coli (RDQK-01)
The residual DNA quantification kit-E.coli is designed for the quantitative analysis of residual DNA fragments derived from E.coli in different products. This kit is based on qPCR assay which is a rapid and reliable detection system. Purified DNA control is included in the kit to generate a standard curve for quantification of the DNA in test samples.
Figure 1. The standard curve of Residual DNA Quantification Kit-E.coli.
Product Data 2: Residual DNA Quantification Kit-CHO (RDQK-03)
The residual DNA quantification kit-CHO is designed for the quantitative analysis of residual DNA fragments derived from CHO cells in different products. This kit is based on qPCR assay which is a rapid and reliable detection system. Purified DNA control is included in the kit to generate a standard curve for quantification of the DNA in test samples.
Figure 2. The standard curve of Residual DNA Quantification Kit-CHO.
Applications for residual DNA quantification kits include:
(1)Biopharmaceutical Manufacturing: In the biopharmaceutical industry, the production of therapeutic proteins, monoclonal antibodies, and vaccines typically involves the use of bacterial, yeast, insect, or mammalian cell lines. After the desired biopharmaceutical product is expressed and purified, it is critical to ensure that residual host cell DNA is reduced to acceptable levels to avoid any adverse effects. Residual DNA quantification kits provide a reliable method to measure the amount of host cell DNA, thereby ensuring that the final product meets regulatory guidelines, such as those established by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
(2)Gene Therapy and Cell Therapy: Gene therapy and cell therapy are revolutionary approaches designed to treat or potentially cure a variety of genetic and acquired diseases. These therapies typically involve the use of viral vectors, such as adeno-associated viruses (AAV) or lentiviruses, to deliver genetic material into a patient's cells. Quantifying residual DNA in these viral vectors or host cells is a critical quality control step. Residual DNA quantification kits enable researchers and manufacturers to monitor and minimize the presence of unwanted genetic material, ensuring the safety and efficacy of the treatment for patients.
(3)Vaccine Development: The development of vaccines, including those based on recombinant DNA technology, typically involves the use of host cells to produce viral proteins or other antigens. It is critical to quantify and control the level of residual host cell DNA in the final vaccine product to ensure it meets regulatory standards. The Residual DNA Quantification Kit provides an accurate and sensitive method to detect and quantify host cell DNA, aiding in the production of safe and effective vaccines.
Q: What is the efficiency of the primer set for the amplification of standard DNA?
A: The efficiency is more than 90%.
Q: Is it require to do any sample preparation before the rDNA testing?
A: Yes. It is recommended to enrich and purify the DNA of the samples by using the Sample Prep Kits.
Q: How can I know if the kits are suitable in our qPCR equipment?
A: The kit is based on a qPCR assay in which FAM or/and VIC signal are used for quantification. A qPCR instrument should have at least two channels, FAM and VIC.
Q: When setting the qPCR program, which quencher should we choose?
A: Please choose 'None'.
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