For use in quality control/manufacturing process only. Others QC Sample Preparation Kit QC Sample Preparation Kit 3.5.3.19.3.7 08 146 829 001 8 146 829 001 08146829001 8146829001 08146829001 QC Sample Preparation Kit QC Sample Preparation Kit 07613336146880 Reagents, kits 1 kit Not Available Unit of measure is “piece”. As a prerequisite for the analysis of samples by PCR, the isolation of the analyte from the cell culture is required.Cell lysis is accomplished by incubation of the sample in a special lysis buffer in the presence of Proteinase K.Subsequently, the DNA is precipitated and purified from salts, proteins, and other impurities by a washing step.In a final step, the DNA is dissolved in a low-salt buffer. en Preparation of cell culture samples before PCR test detection of mycoplasma or residual DNA from CHO cells and from E. coli. en The QC Sample Preparation Kit is designed for:26 extractions from mammalian cell culture samples (per 1 ml), or10 extractions from high density cell culture samples (per 1 ml), or100 extractions from fermentation process samples (per 100 μl).The kit offers optimized extraction protocols to prepare samples for further PCR tests, such as detection of mycoplasma contamination and of host cell DNA.Detection of mycoplasma contaminationUsing a PCR block cycler, refer to the Instructions for Use of the MycoTOOL Mycoplasma Detection Amplification Kit.For testing of CHO or SP2/0 cells with 5 × 106 cells/ml (standard protocol).For testing of CHO or SP2/0 samples up to 1 × 108 cells/ml (protocol for high cell density).Using a real-time PCR instrument, refer to the Instructions for Use of the MycoTOOL Real-Time PCR Kit for testing of mammalian cell culture samples.This PCR kit contains a control plasmid (Recovery Control) that can be added to the sample material to prevent false-negative results.Detection of host cell DNAThe QC Sample Preparation Kit is suitable for processing samples from biopharmaceutical production with host cell impurities from fermentation process to detect residual DNA from E. coli or CHO cells.Refer to the Instructions for Use of the Residual DNA E. coli Kit or the Residual DNA CHO Kit.These PCR kits contain a workflow negative control to prevent false-negative results and a Standard DNA that can be added to the sample material. en Speed up by optimized extraction protocols to prepare samples for PCR tests and gain safety as the Kit does not include any Triton-X . en The kit is designed to be used with the MycoTOOL Mycoplasma Detection Amplification Kit. Additionally it also can be used for the Residual DNA CHO Kit and Residual DNA E. coli Kit. en It is designed for:26 extractions from mammalian cell culture samples (per 1 mL)or 10 extractions from high density cell culture samples (per 1 mL)or 100 extractions form fermentation process (per 100 μL).Stability: At +15 to +25 °C within specification for 24 months. en

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