Solutions
Trypsin solutions
High-purity, animal-free trypsin solutions developed for reliable performance in regulated biopharmaceutical production.
TrypsiNNex®
TrypsiNNex® is a ready-to-use, animal-free recombinant trypsin solution designed for consistent performance in regulated biopharmaceutical manufacturing. Based on recombinant porcine trypsin, TrypsiNNex® supports robust process control with a strong focus on safety, reproducibility, and regulatory readiness.
TrypsiNNex® is suitable for a wide range of biopharmaceutical applications, including cell dissociation, virus production, protein processing, and modification of biological products. By removing animal-derived raw materials, TrypsiNNex® helps reduce contamination risk and supports reliable, scalable manufacturing.
Advantages of TrypsiNNex®
TrypsiNNex® trypsin solutions are engineered to meet the demands of highly regulated biopharmaceutical production environments and offer clear advantages compared to conventional trypsin formulations.
Animal-free
Reduce viral contamination risk from raw materials with animal-free production.
High purity
Deliver consistent process performance with reliably high β-trypsin content.
High quality
Enable smooth qualification or transition with strong documentation and support.
Available trypsin solutions
- 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
Preparation and stock solution
TrypsiNNex® is supplied as a ready-to-use trypsin solution and can be applied directly in your process or used as a stock solution when you prefer to prepare working dilutions to match specific operating conditions. This provides flexibility across different scales and applications while supporting consistent enzymatic performance.
For regulated workflows, consistent handling is important to maintain activity and reproducibility. When preparing working dilutions from a stock solution, use controlled conditions aligned with your process design to help ensure predictable results and reliable downstream performance.
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 and storage: 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.
