TrypsiNNex - Model 0.5 MU -Recombinant Trypsin for Animal-Free Manufacturing
TrypsiNNex is a recombinant trypsin enzyme designed for animal-free biopharmaceutical manufacturing. It features a sequence identical to porcine trypsin, offering a direct replacement option that maintains high levels of β-trypsin. This product is expressed in Escherichia coli as an inactive precursor which is activated during the final phases to ensure a high content of β-trypsin, a crucial quality indicator for consistency in proteolytic patterns. The enzyme’s autolytic properties are controlled throughout production, reducing undesirable activity from intermediate forms like Ψ-trypsin. TrypsiNNex is produced following the Joint Good Manufacturing Practices for Pharmaceutical Excipients and applicable ICH guidelines. With enzymatic activity exceeding 333,000 USP units/ml and a purity level of at least 90%, it supports high-quality processing of precursor proteins. It is supplied in a formulation of 10 mM HCl and 20 mM CaCl2, adhering to strict bioburden controls to guarantee stability and integrity.
The animal-free, recombinant TrypsiNNex sequence is identical to porcine Trypsin and can be used as a direct replacement when converting to animal-free manufacturing. TrypsiNNex is expressed in E. coli as an inactive product. The trypsin remains inactivated during both the upstream and downstream manufacturing process, minimizing the level of auto degradation before final stabilization and packaging, thereby preserving a high content of β-trypsin.
Trypsin has intrinsic autolytic activity and is degraded in steps, where β-trypsin is converted into α-trypsin through proteolytic cleavage (red scissors).
This process continues until the trypsin is inactivated. Intermediate forms such as Ψ-trypsin display unspecific activity, which is undesirable. Thus, a high β-trypsin content is a quality indicator that ensures consistent activity and high specificity.
TrypsiNNex® has a measured β-trypsin of typically well above the minimum specifications at 70% ensuring a high activity and consistent proteolytic pattern, which is critical when processing precursor proteins, such as pro-insulin.
TrypsiNNex is GMP manufactured in accordance with IPEC’s guideline “The Joint Good Manufacturing Practices Guide for Pharmaceutical excipients” (2017) and applicable chapters in pharmacopoeias and ICH guidelines.
- Enzymatic activity*: >333.000 USP units/ml
- Product purity : ≥ 90 % (α- and β-trypsin)
- β-trypsin content: ≥ 70%
- Protein content: 55-85 mg/mL
- Formulation: 10 mM HCl, 20 mM CaCl2
- Bioburden (Microbial Count): ≤ 10 CFU/mL
- Stability: 36 months at –20ºC ±5ºC
- *Alternative units / USP units
- 1 Chromozym TRY Unit: 21 USP Units