Understanding Trypsin and Carboxypeptidase B, GMP Grade
Recombinant Trypsin and Carboxypeptidase B GMP Grade for biopharmaceutical manufacturing
Roche's GMP Grade recombinant Trypsin and Carboxypeptidase B (CpB) are animal-free proteases that deliver exceptional quality and safety for highly regulated biopharma manufacturing processes. Manufactured under a quality management system (QMS) according to ISO 13485:2016 compliance and in GMP Grade quality these enzymes are well suited for GMP production settings. They ensure the reproducibility required for critical applications, including cell detachment for cell and gene therapy, viral activation in vaccine production, and the precision cleavage and trimming necessary for mature insulin production. These specific proteases are essential tools for the modification of therapeutic proteins and the optimization of large-scale biopharmaceutical manufacturing.
- Recombinant Trypsin: High-purity endoprotease expressed in Pichia pastoris (≥ 70% β-trypsin, ≤ 20% α-trypsin). Animal-free to eliminate TSE/BSE risk.
- Recombinant Carboxypeptidase B: Tailored for insulin processing with exceptional purity (<0.005 % trypsin contamination) and high specific activity (> 210 U/mg protein).
- Product quality: Manufactured under a certified ISO 13485:2016 quality management system, extended quality documentation available to support regulatory submissions.
Advantages of choosing Roche GMP Grade Trypsin & Carboxypeptidase B
Our high-purity animal-free proteases deliver the stability and consistency required for regulated biopharmaceutical manufacturing. Supported by extensive documentation, they serve as reliable, high-performance replacements for animal-derived enzymes.
Roche recombinant Trypsin and Carboxypeptidase B offer the following benefits:
- Endotoxin-free:
Ensure superior safety with Pichia pastoris as expression system that minimizes endotoxin levels. - Animal-free:
Eliminate the risk of viral or prion contamination using a fully recombinant manufacturing platform. - GMP Grade quality & scale-up:
Support seamless process transitions with GMP Grade production manufacturing in accordance with ISO 13485:2016 and bulk availability for commercial scale-up.
- Lot-to-lot consistency:
Eliminate batch-to-batch variability and secure highly reproducible performance through tightly controlled manufacturing processes and a proven track record of continuous, narrow-specification batches. - Proven expertise:
Leverage > 20 years of Trypsin and Carboxpeptidase B biomanufacturing experience from Roche CustomBiotech. Originally developed to secure Roche Pharma's own high-value therapeutics.
Applications GMP Grade Trypsin & Carboxypeptidase B (CpB)
Trypsin, rec., GMP Grade and Carboxypeptidase B (CpB), rec., GMP Grade are used for these main applications:
Insulin production
Precision cleavage (Trypsin) and final C-terminal trimming (CpB) of proinsulin precursors into mature, active insulin.
Vaccine manufacturing
Used for the detachment of adherent cell lines and as a viral activator.
Cell and gene therapy
Gentle cell detachment for high-value modalities like CAR-T.
Therapeutic antibodies
Processing and modification of antibody fragments.
Product details Trypsin, rec., GMP Grade and Carboxypeptidase, rec., GMP Grade
| Trypsin, rec., GMP Grade | Carboxypeptidase B, rec., GMP Grade | |
Manufacturing grade |
GMP Grade | GMP Grade |
| Expression host | Pichia pastoris | Pichia pastoris |
| Origin | Animal-free | Animal-free |
| Specific activity | ≥ 180 U/ml (with Chromozym TRY) | ≥ 210 U/mg (with Hippurylarginine) |
| Purity | ≥ 70% β-trypsin, ≤ 20% α-trypsin | ≥ 85% (RP-HPLC) |
| Form | Clear, colorless to slightly yellowish solution | Clear, colorless to slightly yellowish solution |
| pH value | 2 +/- 0.5 | 7.5 - 8.5 (at +25°C) |
| Activation | Autocatalytic activation | Activated via in-house Roche Trypsin, rec., GMP Grade |
| Storage temperature | -15°C to -25°C | -15°C to -25°C |
| Catalog number | 03 358 658 103 (3.5 MU), 06 369 880 103 (1 g) | 03 358 682 103 (30 KU) |
Technical documents
- Certificate of Analysis
ISO 13485:2016 certificate for Roche Diagnostics GmbH Roche Life Science, Penzberg, Germany
- Extended quality documentation:
Statements covering residual solvents, elemental impurities, biological contamination risk, GMP Grade, viral safety, allergens and additives, and nitrosamines.
Statements about packaging details and test methods. Certificates:
Origin (including explicit TSE/BSE statements confirming animal-free status) and stability (including specific shipping and transportation details).- Various other documents available upon request.
Compliance
- Both recombinant products are manufactured under a certified ISO 13485:2016 quality management system.
Production utilizes recombinant expression in the eukaryotic yeast Pichia pastoris, ensuring the entire fermentation, purification, and formulation process is entirely free of animal-derived materials.
The animal-free profile guarantees the complete elimination of TSE/BSE contamination risks.
Storage and shipping
- Shipping: Trypsin and Carboxypeptidase B, rec., GMP Grade are recommended to be shipped at -15°C (dry ice).
- Storage: Both enzymes must be stored at freezing temperatures between -15°C and -25°C immediately upon arrival.
- Dilution: Please contact us for information on storage and handling after dilution.
