Solutions
TrypsiNNex®
Animal-free, recombinant porcine Trypsin
Advantages 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
Trypsin has intrinsic autolytic activity and is degraded in steps, where β-trypsin is converted into α-trypsin through proteolytic cleavage (red scissors).
This process continues until the trypsin is inactivated. Intermediate forms such as Ψ-trypsin display unspecific activity, which is undesirable. Thus, a high β-trypsin content is a quality indicator that ensures consistent activity and high specificity.
TrypsiNNex® has a measured β-trypsin of typically well above the minimum specifications at 70% ensuring a high activity and consistent proteolytic pattern, which is critical when processing precursor proteins, such as pro-insulin.
Resources
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.
- 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).
- TrysiNNex® follows relevant recommendations of USP, chapter <1043> on ancillary materials for cells, gene, and tissue-engineered products and Ph.Eur., chapter <5.2.12> on raw materials of biological origin for the production of cell-based and gene therapy medicinal products.
- 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
TrypsiNNex® Applications
Product list
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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 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.
