Collagenase: a drug substance for wound treatment and as an ultrapure biochemical
At Nordmark, collagenase products are manufactured for two different applications: As active ingredients for wound treatment ointments (Collagenase N Powder) and as biochemicals (Collagenase NB) for use in analytical and medical tissue engineering laboratories. As the World’s largest collagenase manufacturer, Nordmark operates a production plant specifically built for collagenase manufacturing purposes. All Collagenase NB products are marketed and distributed by Nordmark Biochemicals.
Manufacture of Collagenase N
Production takes place in controlled clean rooms and takes place in three stages: Fermentation, purification and aseptic lyophilisation, followed by pulverisation of the sterile collagenase. Please click on the image below for a brief text and picture show.
Manufacture of Collagenase NB
After fermentation, the ultrapure Collagenase NB is chromatographically purified via several columns and subsequently lyophilised directly into vials. Please click on the image below for a brief text and picture show.
We assure the reproducible quality of collagenase by means of in-process controls applied to all manufacturing steps: carefully reviewed manufacturing documentation; production premises monitoring; and the concluding quality inspection. These controls guarantee we meet all international regulatory requirements. All production steps take place in compliance with current international GMP guidelines.
TSE and viral safety
The TSE1 safety of our fermentation product was evaluated and certified by the European Directorate for the Quality of Medicines (EDQM) in accordance with the TSE guidelines (EMA/410/01 Rev. 3). Nordmark produces Collagenase N and Collagenase NB compliant with current TSE guidelines (EMA/410/01 Rev. 3); the entire manufacturing process takes place without the use of specified risk materials.
We assure the viral safety of our collagenase products by steam sterilisation during production. The effectiveness of this procedure was demonstrated in viral safety studies.
1TSE = transmissible spongiform encephalopathy