Proven industrial process – trusted for decades
Our expertise in collagen production is based on more than 80 years of experience in collagen handling and processing at our parent company Naturin Viscofan GmbH. The in-house manufacturing of research, medical and food grade collagen covers the entire workflow from processing of bovine skin splits to the ready-to-use collagen product.
The industrial production process, together with a thorough quality control management according to DIN ISO 9001:2008, ensures a consistent high quality of all our collagen-based biomaterials.
The basis: safe bovine material
Viscofan BioEngineering obtains its bovine raw material for medical applications solely from veterinary-controlled herds in countries where BSE risk is negligible (Category A countries). The feed stock is free of genetically modified organisms (GMO-free). For our collagen products we use bovine skin that has been classified by the World Health Organization (WHO) as a category 4 tissue with no detectable infectivity (same level as milk). This assessment is also shared by the World Organization for Animal Health (OIE).
In addition, our raw material is in compliance with DIN EN ISO 22442 for “medical devices utilizing animal tissues and their derivatives”. In accordance with this norm, we source our collagen from animals with full traceability and keep the raw material strictly separated in all processes to minimize the risk of cross-contamination.
Optimal biocompatibility for basic research & clinical development
The monitoring of our industrial purification, filtration and manufacturing processes ensures the production of ultrapure biocompatible collagen products, consisting of collagen type I. Our routine quality control includes chemical, physical and biological assays as well as microbiological testing, including the determination of endotoxin levels.
The external validation of our products by cooperation partners has confirmed their excellent suitability for basic research applications in cell culture, tissue engineering and regenerative medicine. The high biocompatibility of our collagen I implants has been demonstrated in several in-vivo implantation studies in animals.
Special care for medical grade collagen
All medical grade collagen products are manufactured in Viscofan BioEngineering‘s new facilities according to regulations of good manufacturing practice (GMP).
Our analytical controls follow the guidelines of ASTM F2212-02, a standard guide for characterization of type I collagen as starting material for surgical implants and substrates for tissue engineered medical products (TEMPs).
In addition, our medical products comply with the requirements of the standard for design and manufacturing of medical devices DIN EN ISO 13485 (certification in progress).