To ensure that contaminating substances from the host cell line used to produce biopharmaceuticals are absent from final therapeutic material, Certal Residual DNA Detection Kits deliver a predesigned assay to specifically detect CHO host cell DNA. Each Certal Residual DNA Assay consists of an optimized primer pair and a FAM labeled hydrolysis probe for reliable detection of residual CHO genomic DNA. Human background DNA and Certal Internal Control DNA will not interfere with the Certal Residual DNA Assay.
The premixed Certal Internal Control Assay contains a forward and reverse primer and a MAX labeled hydrolysis probe for the detection of Certal Internal Control DNA. It has been specifically optimized to prevent interference with Certal Residual DNA Assays. The Certal Residual DNA Positive Control enables the correct interpretation of negative results by testing the functionality of the amplification reaction itself.
Certal ResDNA PCR Buffer has been optimized to deliver sensitive and reliable quantitative, duplex real-time PCR results. The master mix also contains dUTP, enabling pretreatment with uracil-N-glycosylase (UNG) prior to starting PCR to ensure that any contaminating PCR products do not affect subsequent PCR reactions.
Certal Residual DNA Detection Kit Components
|Certal Residual DNA Assays and control DNA |
|50x Certal Residual DNA Assay ||Predesigned, optimized, and validated primer-probe set (FAM labeled) ||Reliable detection of residual CHO host-cell DNA|
|Certal Residual DNA Positive Control ||Positive control DNA that will be amplified by the Certal Residual DNA Assay ||Verification that the Certal Residual DNA Assay is working correctly in the case where no residual host-cell DNA is detected in the sample|
|50x Certal Internal Control Assay ||Predesigned, optimized, and validated primer-probe set (MAX labeled) for Certal Internal Control DNA detection ||Specific detection of Certal Internal Control DNA only. Optimized to prevent interference with Certal Residual DNA Assays|
|Certal Internal Control DNA ||Internal Control DNA that will be amplified by the Certal Internal Control Assay ||Excludes the presence of PCR inhibitors or can be used to control purification and amplification when added during the purification step|
|Certal ResDNA PCR Master Mix |
|HotStarTaq DNA Polymerase ||15 min activation at 95°C ||Set-up of qPCR reactions at room temperature|
|Certal ResDNA PCR Buffer ||A balanced combination of KCl and (NH4)2SO4 ions ||Specific primer annealing ensures reliable PCR results|
|Synthetic Factor MP ||Reliable multiplexing analysis of up to 4 genes in the same tube|
|dNTP mix ||Includes dUTP, which partially replaces dTTP and enables optional UNG treatment ||Effective elimination of carryover of PCR products when the reaction is pretreated with uracil-N-glycosylase (UNG)|
|Additional components |
|50x ROX Dye Solution ||Separate tube of passive reference dye for normalization of fluorescent signals on Applied Biosystems 7500 real-time PCR systems. Optional: Can be used on Stratagene instruments from Agilent ||Precise quantification on cyclers that require ROX dye. Does not interfere with PCR on any real-time cycler|
|50x High-ROX Dye Solution ||Separate tube of passive reference dye for normalization of fluorescent signals on Applied Biosystems 7900 and StepOne real-time PCR systems|
|Uracil-N-Glycosylase (UNG) ||Separate tube of pure, nuclease-free recombinant enzyme ||Effective elimination of carryover of PCR products|
|QuantiTect Nucleic Acid Dilution Buffer ||Proprietary buffer formulation for dilution and storage of nucleic acid standards ||Stabilizes RNA and DNA standards during dilution and reaction setup and prevents loss of nucleic acids on plastic surfaces, such as tubes or pipet tips|