Solutions
Trypsin supplier
Novo Nordisk Pharmatech is a trusted worldwide supplier of high-purity, animal-free recombinant trypsin, essential for cell dissociation and biomanufacturing of vaccines.
Global supplier of trypsin for bioprocessing
Novo Nordisk Pharmatech brings over 75 years of expertise across the pharmaceutical value chain, offering high-quality solutions for regulated manufacturing. Our animal-free recombinant trypsin, TrypsiNNex®, provides a safer alternative for bioprocessing by minimizing the risk of contamination and ensuring consistent performance.
As an experienced GMP enzyme manufacturer, we produce our recombinant trypsin under strict excipient GMP conditions to ensure high potency, purity, and reliability. Through rigorous quality control, we help customers enhance product safety and process consistency — ultimately contributing to better outcomes for patients worldwide.
Benefits of choosing TrypsiNNex®
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 product, supported by extensive documentation and support from a preferred pharma grade supplier
TrypsiNNex® Applications
Product list
Get a full overview and find the right solution that makes your process or product better.
Contact our Customer Support to place your order here.
Product information
As a trusted trypsin producer, we manufacture TrypsiNNex® under GMP conditions, following IPEC’s “Joint Good Manufacturing Practices Guide for Pharmaceutical Excipients” (2017) and adhering to relevant pharmacopoeial and ICH guidelines to ensure the highest quality standards.
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
- TrypsiNNex® user guide
- Quality statements: Origin/TSE, impurities, stability, primary packaging, manufacturing, etc.
- ISO 9001, 14001, 45001 certificates for Novo Nordisk Pharmatech’s management systems
- Supplier questionnaire
- SDS documents
- 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
More 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 can recommend using:
- Serum (beta 2 macroglobulin)
- 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.
Although there are no specific regulatory guidelines at this time to specify allowable amounts of residual Trypsin or Collagenase, these are still considered process residuals and potential product contaminants, and thus should be assessed as part of an overall risk mitigation strategy.
Additional resources
More about TrypsiNNex®
TrypsiNNex® applications
TrypsiNNex® specifically addresses the need for a consistent, high-purity and high-quality enzyme in biopharmaceutical manufacturing.
