Solutions

TrypsiNNex®

Animal-free, recombinant porcine Trypsin

What is TrypsiNNex®?

TrypsiNNex® is an animal-free, recombinant porcine trypsin that delivers exceptional performance and consistency for highly regulated biopharma manufacturing processes. Trypsin is a highly specific protease widely used in biopharmaceutical production, ranging from cell dissociation, virus production, to modification of proteins and virus particles.
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Advantages of choosing TrypsiNNex®

TrypsiNNex® offers the following benefits:

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

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.

High β-trypsin content

Trypsin has intrinsic autolytic activity and is degraded in steps, where β-trypsin is converted into α-trypsin through proteolytic cleavage (red scissors):

Trypsin naturally undergoes autolytic degradation, where β-trypsin is gradually converted into α-trypsin through proteolytic cleavage. This process continues until the trypsin is inactivated. Intermediate forms such as Ψ-trypsin display unspecific activity, which is undesirable. For this reason, a high β-trypsin content is a key quality attribute that ensures predictable activity, high specificity, and consistent proteolytic behavior.

TrypsiNNex® recombinant trypsin typically exceeds the minimum β-trypsin specification of 70%, delivering high enzymatic activity and a reliable cleavage pattern. This level of control is particularly important in sensitive applications such as the processing of precursor proteins, including pro-insulin.

TrypsiNNex® applications

TrypsiNNex® is used for three main 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.

TrypsiNNex® 50 MU (future release)

150 ml

3000139

TrypsiNNex® 5 MU (future release)

15 ml

3000138

TrypsiNNex® 0.5 MU

1,5 ml

3000137

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

Other 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. 

Ensuring Removal of Residual Enzymes in Biomanufacturing – Trypsin and Collagenase (downstreamcolumn.com) 

Quantitation of residual trypsin in cell-based therapeutics using immobilized α-1-antitrypsin or SBTI in an ELISA format – ScienceDirect 

Additional resources

SDS documents

Download our TrypsiNNex® product profile

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More about TrypsiNNex®

Novo Nordisk Pharmatech

Københavnsvej 216
4600 Køge,
Denmark
+45 5667 1000
[email protected]

CVR-no. 13246149

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