In-Depth Manufacturing Expertise
Nordmark Pharma’s manufacturing site is located in the northern part of Germany, in Uetersen, a town close to Hamburg:
- Corporate site: 175,000 m2
- Landscaped areas: 120,018 m2
- Built volume: 223,647 m3
- Production area: 11,550 m2
As the world’s largest collagenase manufacturer, Nordmark Pharma operates a production plant specifically built for collagenase manufacturing purposes. Here, for more than 30 years Nordmark Pharma has been producing collagenase as an active pharmaceutical ingredient (API) for wound treatment ointments. Our decades of manufacturing experience and continual improvements have strengthened the robustness and reliability of our process, using state-of-the-art practices and dedicated production facilities. As a result, our manufacturing process delivers products with an extremely high lot-to-lot consistency and allows us to produce precisely controlled enzymes with superior quality and safety.
- Stringent quality control
- Reliable lot-to-lot consistency
- Accurate analysis of proteolytic enzyme activities
- In-process controls
- Manufacturing according to GMP guidelines
The collagenase products are manufactured for two different applications: As an active pharmaceutical ingredient (API) for wound treatment ointments and as a biochemical for use in analytical and medical laboratories.
Manufacturing of Collagenase as a Biochemical
Manufacturing of Collagenase NB 6 GMP Grade
Collagenase NB 6 GMP Grade is a natural blend enzyme ideal for isolation and dissociation of a variety of tissue types like adipose tissue, cartilage, skin, placenta and umbilical cord and is part of our Translational Collagenase NB portfolio. Unique worldwide, this product is produced in controlled clean rooms in three stages: fermentation, purification and aseptic lyophilisation, followed by pulverisation of the sterile collagenase. Filling takes place under aseptic conditions.
Customized filling: Upon request, we are able to carry out customized filling and labelling of the Collagenase NB 6. For more information, please contact us.
Manufacturing of Purified Collagenase NB Products
In some special applications in the field of regenerative medicine (e.g. isolation of islets, TILs and SVF), a purified, more highly active collagenase (Collagenase NB) is required. To meet these requirements, Nordmark Pharma developed a process in which, after fermentation of Clostridium histolyticum, further purification takes place over several chromatographic separation columns. This patented method reliably delivers highly purified Collagenase NB, in lyophilized form in vials with defined activity. The isolation of defined, intact cells from complex tissues is a major challenge, and the demands made on the purity of the collagenase used are correspondingly high.
Manufacturing of Purified Collagenase AF Products
For this first animal–free GMP product worldwide, Nordmark Pharma has developed a process that keeps Clostridium histolyticum on a veggie diet in order to avoid any cross-contamination with animal-derived material. After the fermentation of Clostridium histolyticum with an animal–free source, further purification takes place over several chromatographic separation columns, reliably delivering highly purified Collagenase AF products provided in lyophilized form in vials with defined activity. Being completely free of any animal-based components prevents the risk of transmission of potential animal-derived pathogens and makes these products perfectly designed for clinical applications.
Nordmark’s products are subject to continuous development based on the latest scientific findings, new technologies and a clear understanding of the most recent regulatory requirements. Nordmark guarantees sustainable progress by permanently enhancing and improving our in-house Research and Development functions, especially in terms of environmental protection, economic viability and profitability.