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.
Nordmark’s comprehensive portfolio for tissue digestion is completed by two different anti-collagenase polyclonal antibodies. These antibodies are developed against the natural collagenase blend that includes collagenase class I and class II, neutral protease and clostripain. They can be used for analysis of residual collagenase in cell preparations.
Along with the Anti-Collagenase antibodies, Nordmark offers Collagenase NB Reference Content and Collagenase NB Reference Identity. The Collagenase N Reference products are available for enzyme activity determination or incoming goods inspection according to GMP.
Please contact us should you need further information