{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Residual DNA CHO Kit", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "Residual DNA CHO Kit", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.5.3.19.5.1", "ProductNameAddition": "Kit for determination of residual DNA CHO", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07427689001_im_en.png", "ImageType": "Image main" }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemIdentifier": "OWP_Product_Solutions", "StructureSystemName": "OWP Product Solutions", "NodeName": "CustomBiotech", "NodeID": "520" }, { "StructureSystemIdentifier": "OWP_Organization", "StructureSystemName": "OWP Organization", "NodeName": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "NodeID": "01-01-01-07-00" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Quality Control Testing", "NodeID": "02-0131" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->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": "OWP Product Types", "NodeName": "Assays Reagents and Strips", "NodeID": "20-000-00" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "07427689001", "MaterialDescription": "Residual DNA CHO Kit", "RegisteredProductName": "Residual DNA CHO Kit", "GTIN": "04038377029658", "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": [ { "ProductID": "3.5.3.19.3.2", "BrandName": "MycoTOOL Mycoplasma Real-Time PCR Kit", "ProductNameAddition": "", "ReferenceType": "Reagent" } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Sensitivity range: 0.4 pg/ml to 4 μg/ml", "Name": "Sensitivity" }, { "Language": "en", "Value": "Chinese hamster ovary (CHO) DNA is quantified using a real-time polymerase chain reaction (PCR) assay. 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.", "Name": "Specificity" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "The kit is used as a final drug release test to detect the amount of residual host cell DNA (CHO).", "Name": "Applications" }, { "Language": "en", "Value": "

Vial / bottle	Cap	Label	Function / description	Content
1	white	Workflow Negative Control	To exclude false-positive results.	1 vial, 650 μl
2	white	Dilution Buffer	For preparation of DNA standard dilutions.	5 vials, 1 ml each
3	purple	DNA Stock Solution	40 μg/ml solution.	1 vial, 30 μl
4	red	Reaction Mix, 2x conc.	LightCycler® 480 Probes Master	1 vial, 1 ml
5	orange	UNG	LightCycler® Uracil-DNA Glycosylase; enzyme that digests dUTP-containing DNA.	1 vial, 30 μl
6	green	Detection Mix, 10x conc.	Primers and FAM-labeled detection probe with TAMRA Quencher.	1 vial, 200 μl
7	white	PCR Negative Control	To exclude false-positive results.	1 vial, 50 μl
8	white	Water, PCR Grade	For preparation of working solution. For preparation of master mix.	1 vial, 1 ml

", "Name": "Content" }, { "Language": "en", "Value": "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.

", "Name": "Principle" }, { "Language": "en", "Value": "Quantitative detection of residual DNA from CHO cells in products derived from fermentation processes.", "Name": "Product Characteristics" }, { "Language": "en", "Value": "Each lot of the Residual CHO DNA Kit is function tested using the LightCycler^® 480 Instrument II. PCR is performed on a dilution series of DNA amplified using the Residual DNA CHO protocol.", "Name": "Quality Control" }, { "Language": "en", "Value": "For the testing of cell culture samples for the absence of residual Host Cell DNA from CHO cells.", "Name": "Positioning" }, { "Language": "en", "Value": "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.", "Name": "Product Description" }, { "Language": "en", "Value": "

• Ready-to-use reagents jump start your assay.
• High Quality: Standardized manufacturing according to ISO 13485.\"

", "Name": "Benefits" }, { "Language": "en", "Value": "Stability: At -15 to -25°C within specification range for 24 months.", "Name": "Specification" } ] } } ] }