Solutions
Cell dissociation reagent
Animal-free and high-purity recombinant trypsin developed for efficient and reproducible cell dissociation in regulated biopharmaceutical workflows.
TrypsiNNex® for cell dissociation
TrypsiNNex® is a ready-to-use, recombinant trypsin designed for controlled and effective cell dissociation. As a well-established enzymatic dissociation reagent, trypsin enables the gentle detachment of adherent cells while preserving cell integrity and viability.
Produced using animal-free recombinant technology, ® supports cell dissociation workflows where reproducibility, safety, and regulatory compliance are essential. Its controlled activity allows reliable cell detachment across a range of biopharmaceutical and cell-based manufacturing processes.
Why choose TrypsiNNex®?
TrypsiNNex® is engineered to meet the expectations of highly regulated biopharmaceutical production environments and offers clear advantages when used as a cell dissociation reagent.
Animal-free
Remove animal-derived inputs to strengthen contamination control and support safer cell dissociation workflows.
High purity
Achieve reliable cell dissociation with a highly purified enzyme profile and consistent detachment performance.
High quality
Streamline qualification or changeover with comprehensive documentation and support from a trusted supplier.
How trypsin enables controlled cell dissociation
Cell dissociation is the process of detaching adherent cells from surfaces or separating cells from aggregates using enzymatic treatment. In biopharmaceutical and cell-based manufacturing workflows, controlled cell dissociation is essential to maintain cell viability, functionality, and process consistency.
Cell dissociation is typically performed by applying a dissociation enzyme under carefully controlled conditions such as temperature, exposure time, enzyme concentration, and mechanical handling. These parameters are adjusted to achieve efficient cell detachment while minimizing cellular stress or damage. Consistent dissociation is critical to ensure reproducible cell recovery and reliable downstream performance.
Trypsin plays a central role in cell dissociation due to its well-characterized and predictable proteolytic activity, cleaving proteins involved in cell–surface and cell–cell adhesion. This controlled activity makes trypsin a widely used dissociation reagent in applications where reproducibility and scalability are required. High-quality trypsin with controlled activity and high purity is particularly important, as it supports efficient detachment, reduces variability, and enables consistent cell handling across biopharmaceutical workflows.
Applications of TrypsiNNex®
TrypsiNNex® supports three primary applications:
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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.
