Guarantee patient safety when using KitoZyme’s chitosan in hemostatic products
Julie Marlier met with KitoZyme, a manufacturer of specialty ingredients for well-being, nutrition
and therapeutic solutions, to find out what they will be working on with Notox B.V.
Who is KitoZyme?
KitoZyme, is a European expert and manufacturer of specialty ingredients for high added-value markets, in particular dedicated to well-being, nutrition and therapeutic solutions. One part of our field of expertise is the manufacturing of chitosan and chitin-glucan. These are commercially produced from chitin, which is the structural element in the exoskeleton of crustaceans (crabs, shrimp, etc.) and cell walls of fungi.
Chitosan has many diverse applications. For example, it is currently being studied in the field of biomaterials, including tissue regeneration and bone formation.
Chitin-glucan and chitosan from renewable, safe and traceable fungi
KitoZyme’s patented technology enables the production of high-purity chitin-glucan and chitosan exclusively from renewable, safe and traceable fungi. This ultra-pure chitosan features remarkable characteristics such as 100% animal-free, outstanding traceability and high control on molecular characteristics. This overcomes some of the drawbacks of shellfish-derived ultra-pure chitosan, sets a new benchmark and triggers new developments in therapeutic areas. Think of wound & haemostasis, biosurgery, scaffold & cell therapy and drug delivery & vaccines. For example, the hemostatic, hypoallergenic and natural anti-bacterial properties of Chitosan allow Chitosan hemostatic products (as gel, gauze or powder) to reduce blood loss in comparison to common gauze dressings and increase patient survival.
What are you going to do?
KitoZyme is extending its product portfolio by developing new chitosan derivates that have modified properties compared to chitosan. But one of the main challenges while elaborating pharmaceutical formulations or medical devices is to ensure patient safety when proposing ingredients. To this purpose a battery of in vitro and/or in vivo tests have to be performed. KitoZyme chose to use the FASILIS voucher to perform such studies and therefore guarantee the safety and quality of its new products.
Who are you working with?
Thanks to the FASILIS voucher, KitoZyme will collaborate with NOTOX B.V., a subsidiary of WIL Research Company Inc. NOTOX B.V. specializes in personalized contract research and expert consultancy for the registration of pharmaceutical products and (agro)chemicals worldwide. NOTOX B.V. will carry out in vitro safety evaluations of KitoZyme's pharmaceutical grade products at its headquarters in’s-Hertogenbosch, the Netherlands.
What will the future look like?
The studies performed at NOTOX B.V. will allow KitoZyme to diversify its product portfolio and propose innovative solutions to partners and clients. Moreover, KitoZyme’s development and regulatory activities on the biomedical market and its other target markets require to regularly perform toxicity studies both in vitro and in vivo. KitoZyme and NOTOX B.V. are presently discussing the possible implementation of a 90-days oral toxicity study.