{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For further processing only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "DisclaimerGroup2": null, "ProductNameGlobal": "Carboxypeptidase B recombinant from rat pancreas expressed in Pichia pastoris solution", "DisclaimerGroup1": "Other - Non IVD", "ControlTissue": [ "" ], "BrandName": "Carboxypeptidase B, recombinant", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.1.3.2.3.2", "ProductNameAddition": "from rat pancreas, expressed in Pichia pastoris, solution", "Species": [ "" ], "Clone": "" }, "ProductSpec": { "ProductSpecVariant": { "Chapters": [ { "Language": "English", "Value": "Carboxypeptidase B is a widely used metalloprotease, typically isolated from pancreas of different animals, that specifically releases arginine and lysine from the C-terminus of peptides and proteins. Roche has chemically synthesized a gene encoding for the amino acid sequence of the rat Carboxypeptidase B and has transformed the gene into the expression host Pichia pastoris, which expresses the recombinant Carboxypeptidase B as active protease with identical properties compared to the native Carboxypeptidase B.The production process is validated resulting in a very high lot-to-lot consistency.", "Name": "Product Description" }, { "Language": "English", "Value": "Use the animal component-free and DIN EN ISO 13485-manufactured Carboxypeptidase B, recombinant, as critical raw material for the production of active pharmaceutical ingredients (API), i.e., insulin.", "Name": "Applications" }, { "Language": "English", "Value": "Will be supplied as \"CpB rec.\". Unit of measure is \"MU\".", "Name": "CB - Order Information" }, { "Language": "English", "Value": "Molecular weight: 34.6 kD
The product is manufactured according to DIN EN ISO 13485 .
No animal-derived products are used in the fermentation, purification and final formulation.", "Name": "CB - Properties" }, { "Language": "English", "Value": "Appearance: Clear, colorless to slightly yellowish solution
Storage buffer: Tris/HCl, 33 mmol/L; ZnCl₂, 0.1 mmol/L
pH (at +25°C): 7.5-8.5
Activity (with hippurylarginine): ≥400 U/mL
Total activity: 30 kU ±15%
Specific activity: ≥210 U/mg
Protein: 2.8±0.5 mg/mL
Purity (RP-HPLC): ≥85% according to master lot
Bioburden: ≤50 CFU/mL
Trypsin (with chromozym): ≤0.005%
Shipping conditions: Dry ice
Stability: At -15 to -25°C within specification range for 12 months.", "Name": "CB - Specification" }, { "Language": "English", "Value": "Carboxypeptidase B, recombinant, is intended to use in highly regulated production processes at pharmaceutical companies.", "Name": "Positioning" }, { "Language": "English", "Value": "

• Minimize the risk of virus contamination and the risk of animalrelated cross-contamination.
• Rely on high purity. Minimize the risk of host cell protein contamination in your final product.
• Increase the safety of your production processes with robust and reproducible performance and high lot-to-lot consistency.

", "Name": "Benefits" }, { "Language": "English", "Value": "Carboxypeptidase B, recombinant, is produced completely animal component-free and according to DIN EN ISO 13485.", "Name": "Quality Control" }, { "Language": "English", "Value": "For several years Roche has successfully pursued the strategy of replacing animal-derived enzymes, frequently used in pharmaceutical production processes with recombinant, animal component-free enzymes.
Related products are recombinant Trypsin, recombinant Proteinase K, recombinant DNase I and others.", "Name": "Background Information" }, { "Language": "English", "Value": "Molecular weight: 34.6 kD
The product is manufactured according to DIN EN ISO 13485 .
No animal-derived products are used in the fermentation, purification and final formulation.", "Name": "Properties" }, { "Language": "English", "Value": "Appearance: Clear, colorless to slightly yellowish solution
Storage buffer: Tris/HCl, 33 mmol/L; ZnCl₂, 0.1 mmol/L
pH (at +25°C): 7.5-8.5
Activity (with hippurylarginine): ≥400 U/mL
Total activity: 30 kU ±15%
Specific activity: ≥210 U/mg
Protein: 2.8±0.5 mg/mL
Purity (RP-HPLC): ≥85% according to master lot
Bioburden: ≤50 CFU/mL
Trypsin (with chromozym): ≤0.005%
Shipping conditions: Dry ice
Stability: At -15 to -25°C within specification range for 12 months.", "Name": "Specification" } ] } }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemName": "OWP Product Solutions", "NodeName": "CustomBiotech", "StructureSystemID": null, "NodeID": "520" }, { "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Protease Portfolio", "StructureSystemID": null, "NodeID": "02-0112" }, { "StructureSystemName": "OWP Product Types", "NodeName": "Raw Materials and Reagents->Proteases", "StructureSystemID": null, "NodeID": "70-044-00" }, { "StructureSystemName": "OWP Organization", "NodeName": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "StructureSystemID": null, "NodeID": "01-01-01-07-00" }, { "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Enzymes", "StructureSystemID": null, "NodeID": "02-0014" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "03358682103", "MaterialDescription": "CpB rec.", "RegisteredProductName": "", "GTIN": "07613336131336", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "0.03 MU", "PackSizeDescPIM360": "", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "", "OrderInformation": "Will be supplied as \"CpB rec.\". Unit of measure is \"MU\"." } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "3.1.3.7.21.1", "BrandName": "Trypsin, recombinant", "ProductNameAddition": "Expressed in Pichia pastoris", "ReferenceType": "Reagent" }, { "ProductID": "3.6.14.8.1.6", "BrandName": "Proteinase K, recombinant, PCR Grade", "ProductNameAddition": "from Titrirachium album, expressed in Pichia pastoris, solution", "ReferenceType": "Reagent" } ] } }