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To ensure the safety, potency, purity and identity of the final products, Creative Biogene provides the custom analytical testing services and performs stringent quality control required throughout the viral vector development and production process to accelerate your project to the clinical or commercial market.
Viral vectors produced with cell lines whose host cell residual DNA may deliver tumor or virus-associated genes are potentially infectious and carcinogenic. These residual DNA, despite sharing the same basic structural units, have different fragment lengths, exist in different physical forms, and can cause a wide variety of consequences when they enter the human body. Drug regulatory authorities have strict limits on the amount of residual host cell DNA, while national pharmacopoeias provide several classical assays. Therefore, the establishment of suitable host cell residual DNA assays can help monitor the production process and ensure the safety and quality of viral vectors.
Creative Biogene offers a variety of efficient methods for detecting residual DNA in host cells, providing comprehensive analysis of DNA associated with the viral vector production process, including the cell line used for viral vector packaging production, the risk genes carried by specific cell lines, and the fragment distribution of host cell DNA.
Human DNA residue detection: Specific amplification of Human 293T cell DNA for detection by specific primers and probes.
DNA fragment size assay: Quantify the DNA fragment size distribution in HEK 293T host cell lines during viral vector production.
Considering the potential safety risk of residual DNA in host cells and the impact on product quality, Creative Biogene has established a series of sensitive, accurate and specific methods for the quantitative determination of residual DNA. These methods allow for the analysis of residual DNA at all stages of the viral vector production process.
The exogenous DNA in the test sample is denatured to single-stranded after heating and adsorbed on the solid-phase membrane, and then hybridized with the specifically labeled single-stranded DNA probe at a certain temperature, and the two single-stranded DNA hybridized and compounded into double-stranded DNA, and the hybridization results are displayed using the display system corresponding to the specific marker, and the amount of exogenous DNA residue in the test sample can be determined by comparing with the positive DNA control of known content and the depth of color development reaction DNA.
Select a specific fluorescent dye that can only stain double-stranded DNA. The dye binds to double-stranded DNA to form a complex, and the fluorescence intensity is proportional to the DNA concentration in a certain range of DNA concentration, generating a fluorescence signal under the excitation of 480 nm wavelength, and detecting it at 520 nm wavelength with a fluorescence enzyme marker.
Quantitative detection of ssDNA to calculate the total amount of DNA in the sample based on two DNA sequence non-specific proteins, namely single-stranded DNA (ssDNA) binding protein and anti-ssDNA monoclonal antibody binding to denatured DNA.
Quantitative PCR can detect the amount of product in real time, and the concentration of residual DNA in host cells can be detected by adding a standard sample of known concentration to draw a standard curve, and then projecting the concentration of the initial template according to the position of the sample to be tested in the standard curve.
Creative Biogene's quality control services team can work with clients to provide customized host cell residual DNA assays to meet the demands of viral vector production in-process and batch release testing. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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