{ "ProductData": { "ID": "PID00000007", "ProductType": "Others", "BrandName": "FcRn IgG Control", "ProductNameAddition": "for functional control of the FcRn Affinity Column Gen 2", "RegulatoryDisclaimer1": "For use in quality control/manufacturing process only.", "DisclaimerGroup1": "", "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "FcRn IgG Control" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/FcRn_IgG_Control.jpg", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "NodeID": "90-000-00", "StructureNodeStatus": "valid", "NodeName": "Controls" }, { "StructureSystemIdentifier": "OWP_Organization", "StructureSystemName": "Organization", "NodeID": "01-01-01-07-00", "StructureNodeStatus": "valid", "NodeName": "CustomBiotech and LifeScience" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeID": "520", "StructureNodeStatus": "valid", "NodeName": "CustomBiotech" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeID": "180-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "02-0052", "StructureNodeStatus": "valid", "NodeName": "In vitro Glycoengineering" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeID": "999", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "02-0008", "StructureNodeStatus": "valid", "NodeName": "Biologics" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "02-0001", "StructureNodeStatus": "valid", "NodeName": "Affinity Columns" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeID": "290-00", "StructureNodeStatus": "valid", "NodeName": "Affinity Column Chromatography" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "09494804001", "MaterialDescription": "FcRn IgG Control", "RegisteredProductName": "FcRn IgG Control", "GTIN": "07613336207857", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "1 mL", "PackSizeDescPIM360": "Not Available", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "", "OrderInformation": "Unit of measure is one piece." } ] }, "Product2Products": { "Product2ProductReference": [ ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Name": "Positioning", "Value": "Control solution for reliable and convenient quality control of the FcRn Affinity Column Gen2.", "Language": "en", "Country": "XG", "Code": "Positioning" }, { "Name": "Product Description", "Value": "The FcRn IgG Control provides an easy and reproducible check for the column functionality. Custom preparations of IgG or albumin can be used for additional control.", "Language": "en", "Country": "XG", "Code": "Product Description" }, { "Name": "Applications", "Value": "The FcRn IgG Control contains a preparation of a monoclonal IgG antibody and two oxidized variants thereof. The product is intended for quality control of the FcRn Affinity Column Gen2 to verify the correct separation performance.", "Language": "en", "Country": "XG", "Code": "Applications" }, { "Name": "Specification", "Value": "Volume: 0.2 mL concentrate, to be reconstituted to 1 mL control solution, sufficient for ≥ 30 test runs within the stability period
Test result: Chromatography on the FcRn Affinity Column Gen2 results in 3 distinguishable peaks.", "Language": "en", "Country": "XG", "Code": "Specification" }, { "Name": "Content", "Value": "

Label	Function / description	Content
FcRn IgG Control	Control solution: 0.2 mL concentrate to be diluted to 1 mL of final working solution. Stable concentrate for dilution with buffer to prepare a ready-to-use control solution. For preparation of an IgG with structural variants that can be separated by the FcRn Affinity Column Gen2*.	1 vial, 1 mL

", "Language": "en", "Country": "XG", "Code": "Content" }, { "Name": "Principle", "Value": "The FcRn IgG Control contains a preparation of an IgG that was partially oxidized to produce two structure variants, which can be separated and detected using the FcRn Affinity Column Gen2. If a column is no longer able to show a clear separation of these variants, then its functional performance may no longer be acceptable.
For more detailed background information about the different structures of the variants and their preparation, see the publication: Stracke J, et al, 2014.", "Language": "en", "Country": "XG", "Code": "Principle" } ] } } ] }