For use in quality control/manufacturing process only. Others Residual DNA CHO Kit Residual DNA CHO Kit 3.5.3.19.5.1 Kit for determination of residual DNA CHO 07427689001 Residual DNA CHO Kit Residual DNA CHO Kit 04038377029658 Reagents, kits 1 kit 96 PCRs each with a 20 µL final reaction volume CustomBiotech product. Please contact your local representative. Unit of measure is "piece". The Residual DNA CHO Kit is designed for fast, highly sensitive and specific real-time PCR analysis of host-cell residual DNA from Chinese hamster ovary (CHO) cells in biomanufacturing processes. Host cell impurities such as residual DNA can be easily quantified with this kit during the purification process.The broad range allows testing of samples, such as in-process controls with higher amounts of DNA and bulk samples with very low amounts of DNA. The assay is accurate and reliable across a broad range of sample types, from in-process samples to final product.The kit uses specific PCR of highly conserved regions within DNA from CHO cells. Highly specific primers and one hydrolysis probe are included in the detection mix. The probe is labeled with a fluorescent dye (FAM) detected by real-time PCR instruments.A ready-to-use hot start reaction mix for detecting DNA targets with hydrolysis probes is included. The chemically modified polymerase enzyme is inactive during initial PCR setup, thereby avoiding nonspecific elongation of primer-template hybrids forming at lower temperature. The polymerase is irreversibly activated by an initial activation step at higher temperature.To exclude false-positive results, a Workflow Negative Control and a PCR Negative Control are also included. en For the testing of cell culture samples for the absence of residual Host Cell DNA from CHO cells. en The Roche residual DNA CHO Assay, based on proven real-time qPCR technology, makes testing of residual DNA from the Chinese hamster ovary (CHO) cell line fast and reliable. It allows for high-confidence testing across a broad range of sample types, from in-process samples to bulk drug substance.The kit was developed to meet the sensitivity requirements defined by WHO (10 ng CHO DNA per therapeutic dose).Linearity is demonstrated by analysis of CHO cell standard DNA ranging from 4 pg/mL to 400 ng/mL.The PCR-based assay is sensitive and specific for DNA from the CHO cell line and not subject to detection of human or environmental DNA that might be introduced during sample handling. en Ready-to-use reagents jump start your assay. High Quality: Standardized manufacturing according to ISO 13485." en Stability: At -15 to -25°C within specification range for 24 months. en The Residual DNA CHO Kit is designed for the quantification of residual DNA in products derived from fermentation processes of Chinese hamster ovary (CHO) cells. Purified DNA control from CHO cell line (DNA Stock Solution, Vial 3) is included in the kit to generate a standard curve for quantification of the DNA in test samples. en