{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Residual DNA E. coli Kit", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "Residual DNA E. coli Kit", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.5.3.19.5.2", "ProductNameAddition": "Kit for determination of residual DNA E.coli", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07728735001_im_en.png", "ImageType": "Image main" }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "Cell & Gene Therapy", "NodeID": "02-0133" }, { "StructureSystemIdentifier": "OWP_Organization", "StructureSystemName": "Organization", "NodeName": "CustomBiotech and LifeScience", "NodeID": "01-01-01-07-00" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "Quality Control Testing", "NodeID": "02-0131" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "Impurity Testing", "NodeID": "02-0060" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "NodeName": "Impurity Testing", "NodeID": "10-00-00" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "NodeName": "Residual Testing", "NodeID": "20-00-00" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeName": "CustomBiotech", "NodeID": "520" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "NodeName": "Assays Reagents and Strips", "NodeID": "20-000-00" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeName": "Manufacturing", "NodeID": "180-00" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeName": "NOT APPLICABLE", "NodeID": "999-00" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeName": "NOT APPLICABLE", "NodeID": "999" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeName": "NOT APPLICABLE", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "NodeName": "NOT APPLICABLE", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "NodeName": "NOT APPLICABLE", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "Biologics", "NodeID": "02-0008" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "07728735001", "MaterialDescription": "Residual DNA E.coli Kit", "RegisteredProductName": "Residual DNA E. coli Kit", "GTIN": "04038377029740", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "1 kit", "PackSizeDescPIM360": "96 PCRs each with a 20 µl final reaction volume", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "", "OrderInformation": "Unit of measure is \"piece\"." } ] }, "Product2Products": { "Product2ProductReference": [ ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Limit of Detection (LOD): 1 pg/ml
Limit of Quantification (LOQ): 5 pg/ml", "Name": "Sensitivity" }, { "Language": "en", "Value": "Escherichia coli DNA is quantified using a real-time PCR assay. The PCR-based assay is sensitive and specific for DNA from E. coli cells and not subject to detection of human or environmental DNA that might be introduced during sample handling.", "Name": "Specificity" }, { "Language": "en", "Value": "
Vial / bottleCapLabelFunction / descriptionContent
1whiteWorkflow Negative ControlTo exclude false-positive results.1 vial,
700 μl
2whiteDilution BufferFor preparation of DNA standard dilutions.5 vials,
1 ml each
3aredFastStart Enzyme• Ready-to-use hot start PCR reaction mix.
• Contains FastStart Taq DNA Polymerase, reaction buffer, uracil-N-glycosylase, and dNTP mix (with dUTP instead of dTTP).
1 vial,
30 μl
3bredFastStart Reaction Mix, 5x conc.1 vial,
600 μl
4purpleDNA Stock Solution50 μg/ml solution.1 vial,
40 μl
5blueMgCl2, M-grade, 25 mMFor preparation of master mix.1 vial,
200 μl
6greenDetection Mix, 10x conc.Primers and FAM-labeled detection probe with BHQ2 Quencher.1 vial,
200 μl
7whitePCR Negative ControlTo exclude false-positive results.1 vial,
100 μl
8whitePCR Water M-grade
  • For preparation of working solution.
  • For preparation of master mix.
1 vial,
1 ml
", "Name": "Content" }, { "Language": "en", "Value": "Each lot of the Residual DNA E. coli Kit is function tested using the LightCycler® 480 Instrument II. PCR is performed on a dilution series of DNA amplified using the PCR protocol of the Residual DNA E. coli Kit.", "Name": "Quality Control" }, { "Language": "en", "Value": "Quantitative detection of residual DNA from E. coli in products derived from fermentation processes.", "Name": "Product Characteristics" }, { "Language": "en", "Value": "The kit is used as a final drug release test to detect the amount of residual host cell DNA (E. coli).", "Name": "Applications" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "The Roche Residual DNA E. coli Kit, based on proven real-time qPCR technology, makes testing of residual DNA from E. coli bacteria 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 has a high sensitivity (LOD 1 pg/mL [10 fg/reaction]) and has been developed to meet WHO requirements. These characteristics are largely due to highly pure DNA-free buffers and enzymes supplied with the assay. An optimized sample preparation protocol for excellent DNA Recovery (min 80%) is available.
The PCR-based assay is sensitive and specific for DNA from E. coli cells and not subject to detection of human or environmental DNA that might be introduced during sample handling.", "Name": "Product Description" }, { "Language": "en", "Value": "For the testing of cell culture samples for the absence of residual host cell DNA from E. coli bacteria.", "Name": "Positioning" }, { "Language": "en", "Value": "
  • Ready-to-use reagents jump start your assay.
  • High Quality: Standardized manufacturing according to ISO 13485. Change notification also available.
", "Name": "Benefits" }, { "Language": "en", "Value": "The PCR-based assay is sensitive and specific for DNA from E. coli cells and not subject to detection of human or environmental DNA that might be introduced during sample handling.
Stability: At -15 to -25°C within specification range for 24 months.", "Name": "Specification" }, { "Language": "en", "Value": "Limit of Detection (LOD): 1 pg/mL
Limit of Quantification (LOQ): 5 pg/mL", "Name": "Properties" } ] } } ] }

Residual DNA E. coli Kit

Kit for determination of residual DNA E.coli

Residual DNA E.coli Kit