Solutions
Trypsin for protein digestion
High-purity, animal-free recombinant trypsin designed for precise and reproducible protein digestion in regulated biopharmaceutical workflows with consistent cleavage patterns.
Introducing TrypsiNNex®
TrypsiNNex® is a ready-to-use, recombinant trypsin developed to deliver controlled and highly specific protein digestion. Produced using animal-free recombinant technology, TrypsiNNex® supports workflows where cleavage precision, reproducibility, and product integrity are critical.
For protein digestion, consistent enzymatic performance is essential to ensure predictable cleavage patterns and reliable downstream results. TrypsiNNex® is engineered to meet these requirements while supporting regulatory compliance and risk-mitigated manufacturing.
Why choose TrypsiNNex® for protein digestion?
TrypsiNNex® is engineered to meet the expectations of highly regulated biopharmaceutical production environments and offers distinct advantages for protein digestion applications.
Animal-free
Reduce the risk of adventitious agents and viral contamination by eliminating animal-derived raw materials.
High purity
Support consistent digestion performance through a controlled enzyme profile with a high β-trypsin content.
High quality
Enable smooth qualification or transition, supported by extensive documentation and support from a preferred supplier.
How trypsin enables precise protein digestion
Protein digestion is the process of breaking down proteins into smaller, well-defined peptides through enzymatic cleavage. In biopharmaceutical and life science applications, controlled protein digestion is used to enable protein characterization, modification, and processing, where precision and reproducibility are essential.
Protein digestion is typically performed by adding a proteolytic enzyme to a protein solution under carefully controlled conditions such as pH, temperature, enzyme-to-substrate ratio, and incubation time. These parameters are adjusted to achieve a predictable cleavage pattern while preserving the integrity of the target molecule. Consistent digestion is critical to ensure reliable downstream results and comparability across batches.
Trypsin plays a central role in protein digestion due to its high specificity, cleaving peptide bonds at the carboxyl side of lysine and arginine residues. This well-defined cleavage behavior makes trypsin a preferred enzyme for applications where reproducible and well-characterized digestion patterns are required. High-quality trypsin with a high β-trypsin content is particularly important, as it ensures precise cleavage, minimizes non-specific activity, and supports consistent digestion performance across biopharmaceutical workflows.
Applications of TrypsiNNex®
TrypsiNNex® supports three primary applications:
Product list
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Product information
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
1 Chromozym TRY Unit: 21 USP Units
(Source: www.omicsonline.org)
- Certificate of analysis
- ISO 9001, 14001, 45001 certificates for Novo Nordisk Pharmatech’s management systems
- TrypsiNNex® user guide
- Quality statements: Origin/TSE, impurities, stability, primary packaging, manufacturing, etc.
- Regulatory Support File
- Supplier questionnaire
- SDS
- EcoVadis Sustainability report
- Novo Nordisk Pharmatech’s quality system meets DS/EN ISO 9001 and Novo Nordisk Pharmatech’s environmental systems meet DS/EN ISO 14001 and 45001.
- TrypsiNNex® is manufactured in accordance with GMP as defined by Novo Nordisk Pharmatech based on applicable chapters in DS/EN ISO 9001 and IPEC GMP guidelines for excipients (current version).
- TrypsiNNex® is produced by recombinant microbial expression in E.coli. No ingredients of animal origin are used in the cell banking and manufacturing process.
- TrypsiNNex® is antibiotic-free, both in production facilities and on a cell bank level.
- TrypsiNNex® is animal-free, meaning it is TSE compliant
Practical information
TrypsiNNex® is shipped on dry ice.
TrypsiNNex® should be stored at ‑20°C ±5ºC immediately upon arrival.
Please contact us for information on storage and handling after dilution.
If trypsin inhibitors are needed, we recommend using regular animal-free trypsin inhibitors, e.g. a Soybean Trypsin inhibitor.
In Biopharmaceutical production, detection of raw material is necessary:
- Incoming testing of TrypsiNNex® (e.g. identity, activity)
- Detection of residual raw material in the finished product (LOQ for HPLC-based purity measurement)
For support on incoming quality testing, please contact us.
Additional resources
More about TrypsiNNex®
TrypsiNNex® applications
TrypsiNNex® specifically addresses the need for a consistent, high-purity and high-quality enzyme in biopharmaceutical manufacturing.
