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TrypsiNNex® FAQ

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We do offer product samples for process development, testing and qualification. Contact us here to request a sample.

TrypsiNNex® is used for three main applications:

 

For more information and performance results, click on any of the topics above to access our Applications page.

Yes. TrypsiNNex® contains recombinat trypsin produced by recombinant expression of a synthetic gene sequence for porcine trypsin, followed by downstream purification. Thus, TrypsiNNex® is a direct replacement for porcine-derived trypsin, and can be implemented with minimal process adjustments.

TrypsiNNex® is a high-quality recombinant enzyme that addresses critical raw material specifications for biopharmaceutical processing. Its unique manufacture mitigates premature autolysis, safeguarding the compositional purity of TrypsiNNex® and ensuring top proteolytic performance. This compositional and functional stability enhances process consistency via enzymatic cleavage or transpeptidation. Novo Nordisk Pharmatech supplies TrypsiNNex® with a comprehensive documentation package for process validation, facilitating a smooth transition away from porcine or bovine trypsin or a conversion from another recombinant source, in alignment with industry standards for non-animal origin raw materials. These attributes make TrypsiNNex® a reliable and flexible choice for biopharmaceutical processes, offering purity, stability, and performance in manufacturing.

While recombinant trypsin has the advantage of being free from animal-derived contaminants, transitioning from animal-derived to recombinant trypsin is considered a significant modification in the manufacturing process, requiring regulatory notification or approval. The impact on the final product’s quality, efficacy, and safety must be evaluated. Clinical studies are conducted on the final product and are not necessary if the change does not significantly impact the final product´s characteristics. Comparative studies and validation data are typically required to demonstrate that the recombinant trypsin performs equivalently to the animal-derived trypsin.

Relevant guidelines include:

All raw materials used for the manufacturing of our recombinant TrypsiNNex®, including the primary packaging, are certified as animal-free and TSE-free materials. This is supported by supplier documentation, supplier quality agreements and supplier audits.
 
Our strict quality requirements ensure full traceability in the supply chain.
 
Moreover, our validated processes for recombinant manufacturing help ensure a very low bioburden in terms of endotoxins and microbial count, as specified on batch level.

TrypsiNNex® is available in three volume sizes:

TrypsiNNex® 0.5MU
Packaging size: 1,5 mL
Item no. 3000137

TrypsiNNex® 5 MU
Packaging size: 15 mL
Item no. 3000138

TrypsiNNex® 50 MU
Packaging size: 150 mL
Item no. 3000139

TrypsiNNex® is dispensed into a range of PTEG plastic containers with HDPE lids, which are placed in individual tamper-proof plastic bags. The tamper-proofed containers are placed in approved thermo containers, inside a cardboard box and packed with dry ice to ensure that the product is kept below the recommended maximum temperature during shipment.

Based on research material, TrypsiNNex® currently has a 3-year shelf life. Our two locally placed distribution centers – near Copenhagen, Denmark, and in Indiana, USA – will ensure short lead-times and precision delivery worldwide.

TrypsiNNex® is dispensed into a range of PTEG plastic containers with HDPE lids, which are placed in individual tamper-proof plastic bags. The tamper-proofed containers are placed in approved thermo containers, inside a cardboard box and packed with dry ice to ensure that the product is kept below the recommended maximum temperature during shipment.

TrypsiNNex® is supplied as a concentrate for convenient transport, and storage. This allows to optimize the enzyme concentration in the work solution.

We will provide customers with a guide on how to handle, store and dilute TrypsiNNex®. Additionally, the user guide can be downloaded on the TrypsiNNex® application page.

Our customers are provided with a dilution guide for the preparation of stock solutions.
In our application note on Cell Dissociation, you can find examples of TrypsiNNex® concentrations in use with different types of cells.
Store TrypsiNNex® at -20°C +/-5°C in its original container, to avoid potential degradation and to ensure compliance with the product specification for the entire shelf-life period. These recommendations and limitations apply from the time of shipment from Novo Nordisk Pharmatech and refer to the original primary packaging container.
 
A working solution of TrypsiNNex® with a concentration of 70 U/mL and stored at 4°C holds a stable total trypsin concentration and a high ratio of β-trypsin to α-trypsin for 6 months. While autolytic degradation and an overall decrease in trypsin concentration do occur, the composition of the TrypsiNNex® solution is especially stable for 15–20 days (Figure 2A). This compositional consistency is reflected in the proteolytic activity of TrypsiNNex®. Overall activity declines only about 12% over the 6 months and is constant for the first 2 weeks.
 
TrypsiNNex® can be stored at refrigerator temperature (+2 to +8°C) for up to 14 days in total, accumulated over its 3-year shelf-life period. Within the shelf-life period, the product should not be thawed/re-frozen more than five times. In order to dispense the product for use, handling and storage at up to 25°C is allowed for up to 24 hours. The dispensed product should be kept at +2 to +8°C until use.

TrypsiNNex® currently has a 3-year shelf life when kept in its original container at -20°C +/-5°C.

Quality audits at our headquarter in Denmark can be booked with our QA department.
 
Please contact us for more information.

TrypsiNNex® is manufactured according to GMP as defined by Novo Nordisk Pharmatech based on applicable chapters in pharmacopoeias, IPEC excipient guideline and ICH guideline. This is ensured by Novo Nordisk Pharmatech A/S’ QMS processes anchored throughout the entire organization’s activities. A carefully validated and monitored manufacturing process ensures product quality consistency.

TrypsiNNex® is analyzed according to the current United States Pharmacopoeia (USP). Novo Nordisk Pharmatech is regularly audited by major and minor pharmaceutical companies, as well as health authorities and notified bodies. High product purity and activity is achieved through our manufacturing process.

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. A high β-trypsin content is a quality indicator that ensures consistent activity and high specificity.

TrypsiNNex® has a measured β-trypsin purity of typically well above the minimum specifications of >70% and ensures high activity and consistent proteolytic pattern.

We provide a simple, ‘one-stop’ solution to regulatory compliance, providing you with what you need in a fast and convenient way. You have our full support for your questions and requests well after supplier qualification, from first delivery and throughout your whole product life cycle. Tailored to the level of service you need; our comprehensive documentation and support package includes:

  • ISO 9001 Certificate from Novo Nordisk Pharmatech
  • Certificate of Analysis
  • Customer audits
  • Quality agreements
  • Declarations and statements
  • Change Notification
  • Answering of questionnaires
  • Process flowchart
  • Packaging details
  • Safety Data Sheet

TrypsiNNex® can be purchased from Novo Nordisk Pharmatech in Denmark.

TrypsiNNex® is manufactured in Denmark.

From Novo Nordisk Pharmatech’s warehouse in Denmark.

Where can I learn more?

For more information about our TrypsiNNex®, please contact us or visit our TrypsiNNex® product page.
Read more about TrypsiNNex®
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More about TrypsiNNex®

 TrypsiNNex®

Reduce resources needed for validation, improve process consistency and reduce costs due to contamination risk with our animal-free, recombinant TrypsiNNex®.

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Novo Nordisk Pharmatech

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

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