Translational Collagenase NB
Step By Step at Your Side
We, the product management team, are constantly approached by customers who are in urgent need of GMP collagenase. Often, the customers are already using a collagenase available in research grade only, experiments are going well and efficacy has been demonstrated. At this point, they want to make the transition to the clinical environment and are confronted by GMP guidelines and requirements for careful selection of raw materials.
This is the point at which collagenase users approach Nordmark Biochemicals and seek GMP collagenase alternatives. Other collagenase suppliers do not offer GMP versions of their research collagenases, or they do not offer Drug Master Files for application with the FDA, or regulatory support in general. We are able to offer GMP collagenase alternatives in these cases, but customers often need to adjust their protocols slightly when switching between collagenase manufacturers, which is time consuming and costly.
That is the reason we developed our Translational Collagenase NB: Affordable research grade collagenases and highly regulated GMP collagenases with almost the same enzymatic activities to ensure an easy switch between grades without any protocol adjustment.
This major advantage saves time, money and frustration on the way to clinical applications.
Can I Use Collagenase NB in My Application? - YES, You Can!
Every application of collagenases places different demands on optimal digestion conditions. Nordmark Collagenase NB products range from standard collagenases containing balanced amounts of other proteolytic activities to highly purified collagenases, in both research and GMP grades. For this reason, our collagenase products are exceptionally suitable for a variety of cell isolation applications. Our customers do not need to worry about choosing a collagenase for their research because we can provide a suitable GMP collagenase alternative in our Translational Collagenase NB Concept.
Our Translational Concept includes our Collagenase NB products with a naturally balanced ratio of collagenase and protease enzymes, as represented by Collagenase NB 4 Standard Grade for research and Collagenase NB 6 GMP Grade for clinical applications.
We also offer purified collagenases and proteases as part of our Translational Concept. Collagenase NB 1 Premium Grade & Neutral Protease NB are ideal tools in basic research experiments, whereas Collagenase AF-1 GMP Grade & Neutral Protease AF GMP Grade not only meet GMP requirements, but are also free of animal-based components.
Don’t get lost in translation. Take the direct route with Nordmark.
GMP Collagenase for Clinics
GMP Collagenase NB
Enzymes for tissue dissociation are critical raw materials for tissue engineering and cell transplantation into humans. To meet the demanding requirements for these applications, Nordmark Biochemicals offers excellent GMP grade Collagenase NB and Neutral Protease NB products that are manufactured in compliance with the EU-Guide to Good Manufacturing Practice (GMP). In addition, TSE safety of the products is certified and virus validation studies have been performed.
Superb quality and performance of our highest standard GMP Grade enzymes are assured by:
- stringent quality control
- reliable lot-to-lot consistency
- accurate analysis of proteolytic enzyme activities
- in-process controls
- production according to GMP guidelines
Animal-Free GMP Collagenase
Animal-Free (AF) products are our superior enzymes designed to provide the highest possible safety for clinical applications. A plant-based production process and the use of carefully selected materials ensure that there is no commingling with components of animal origin. As a result, any risk of introducing potential animal-derived pathogens is avoided in the first place. Additionally, the sophisticated production process prevents cross-contamination with any animal-derived materials. The animal-free enzymes are produced in compliance with GMP guidelines that guarantee the highest quality and a reliable lot-to-lot consistency. These enzymes provide the highest level of safety and reduced regulatory hurdles.
Collagenase AF-1 GMP Grade and Neutral Protease AF GMP Grade represent the first choice for clinical isolation of especially sensitive cells like pancreatic islets, hepatocytes and tumor cells.
Collagenase for Research
Every application requires a different collagenase for optimal digestion conditions. For this reason, Nordmark offers several collagenase products with varying enzymatic activities for research and protocol development in multiple application fields.
Nordmark collagenase products range from standard collagenases, containing balanced amounts of other proteolytic activities, to highly purified collagenases. Our products are particularly suitable for gentle and efficient dissociation of numerous tissue types, leading to high yields of viable cells.