Solutions
Recombinant Trypsin
High-purity, animal-free recombinant trypsin designed for consistent performance in regulated biopharmaceutical manufacturing.
What is recombinant trypsin?
Recombinant trypsin is a genetically engineered form of trypsin produced using recombinant technology to ensure safety, consistency, and regulatory compliance. TrypsiNNex® is our animal-free recombinant porcine trypsin, developed for use in biopharmaceutical manufacturing processes.
Recombinant trypsin is widely applied across biopharmaceutical workflows, including cell dissociation, virus propagation, protein processing, and modification of viral and protein-based products. By eliminating animal-derived raw materials, TrypsiNNex® supports modern, risk-mitigated manufacturing strategies.
Why choose TrypsiNNex®?
TrypsiNNex® is engineered to meet the expectations of highly regulated biopharmaceutical production environments and offers multiple advantages over conventional trypsin products.
Animal-free
Eliminate the risk of viral contamination from raw material
High purity
Achieve high process consistency owing to consistently high β-trypsin content
High quality
Easy qualification or transition from your existing trypsin source, supported by extensive pharma grade documentation
Recombinant trypsin identical to porcine trypsin
High β-trypsin content
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.
