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 07 427 689 001 7 427 689 001 07427689001 7427689001 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 reliable detection of residual host cell DNA in CHO cell culture samples. en The Residual DNA CHO Kit is based on real-time qPCR technology to facilitate the detection of residual DNA from the Chinese hamster ovary (CHO) cell line. This assay allows for reliable testing across a variety of sample types, including in-process samples and bulk drug substances. Designed to meet the World Health Organization's (WHO) sensitivity requirements, the assay can detect residual DNA at levels as low as 10 ng of CHO DNA per therapeutic dose. This PCR-based assay is sensitive and specific to CHO cell DNA, minimizing detection of human or environmental DNA that could 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

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