3936
What is the amount of standard for the different kit?
The standard that is provided has an amount of 1000 pg that will be diluted with 100 µL of rehydration buffer down to working solution of 10 pg/µL.
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QIAcuity Residual DNA Quantification Kits
Host cell DNA contamination in products such as vaccines, drugs and other biopharmaceuticals imposes great health risks. Therefore, its safe limits are tightly regulated by agencies such as the U.S. FDA and WHO. Clear guidelines for the upper limits of residual DNA are established based on the nature of drug administration, infectivity and oncogenicity of the contaminating cell DNA. For instance, parenteral administration of non-tumorigenic cell DNA should be limited to 10 ng/dose and a maximum length of 200 bp, whereas less than 100 µg/dose of residual DNA is recommended by WHO for orally administered vaccines.
Detection and removal of such contaminations in manufacturing products require highly sensitive and accurate measurements of the extremely low amounts of specific host cell DNA present in the products.
Digital PCR is the preferred method of detection for residual DNA quantification. This is due to its unmatched sensitivity and accuracy, especially at trace levels of contamination compared to other detection methods such as qPCR. QIAcuity Residual DNA Quantification Kits provide the accurate and precise detection of Escherichia coli (E.coli), Chinese Hamster Ovary cell (CHO) and Human Embryonic Kidney 293 cells (HEK293) host cell DNA.