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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": "en", "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": "en", "Value": "Will be supplied as \"CpB rec.\". Unit of measure is \"MU\".

 ", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Carboxypeptidase B, recombinant, is intended to use in highly regulated production processes at pharmaceutical companies.", "Name": "Positioning" }, { "Language": "en", "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": "en", "Value": "Carboxypeptidase B, recombinant, is produced completely animal component-free and according to DIN EN ISO 13485.", "Name": "Quality Control" }, { "Language": "en", "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": "en", "Value": "CAS Number: 9025-24-5
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": "en", "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" } ] } } ] }