Recombinant Trypsin, GMP Grade
CAS No. 9002-07-7
GMP-grade recombinant trypsin for cell dissociation
Ordering Information
Overview
Recombinant Trypsin GMP Grade is an animal-component free serine protease manufactured under GMP conditions for use in mammalian cell culture dissociation, downstream processing and GMP-aligned analytical workflows. It replaces porcine pancreas-derived trypsin, eliminating adventitious agent risk while delivering defined specific activity and full regulatory documentation. Available as a lyophilized powder in scalable formats from 1 g to 25 g.
Key Benefits
GMP-grade manufacture with full documentation including Certificate of Analysis and Certificate of Origin
Recombinant and animal-component free, eliminates adventitious agent and TSE/BSE risk associated with porcine-derived trypsin
Defined specific activity and cleavage specificity for consistent and reproducible performance in cell culture and manufacturing workflows
Suitable for mammalian cell dissociation, passaging and harvest in GMP cell culture processes
Compatible with standard biopharmaceutical manufacturing buffer systems
Supports regulatory compliance with ICH Q5A and EMA guidelines on use of animal-derived reagents in biological manufacturing
Available in 1 g, 5 g and 25 g formats supporting process development through commercial-scale manufacturing
Lyophilized format offers extended shelf life and flexibility in reconstitution concentration
Product Specifications
| Grade | GMP Grade |
| Enzyme Source | Recombinant; animal-component free |
| Specificity | Cleaves C-terminal to Lys and Arg residues |
| Form | Lyophilized Powder |
| Storage Condition | −15°C to −25°C |
| Optimal pH | 7.5–8.5 |
| Activator | Ca²⁺ stabilizes enzyme; activity in standard buffers without calcium supplementation |
| Inhibition | Inhibited by PMSF, TLCK, soybean trypsin inhibitor and serum |
| Purity | Defined by SDS-PAGE and activity assay; CoA provided per lot |
| Documentation | CoA, Certificate of Origin and GMP compliance documentation available |
