The company KitoZyme has established a patented and fully validated GMP process for the manufacturing of ultra-pure chitosan, a bioresorbable cationic biopolymer, from white edible mushrooms. It conforms to the requirements for use in all pharmaceuticals applications including parenteral, and in all medical devices including implants.
Kitozyme's technology permits a tight management of the molecular characteristics of chitosan, enabling for the first time to supply an ultra-pure GMP chitosan now in 4 different molecular weights, available from KitoZyme and in smaller quantities through Sigma-Aldrich. This enables the medical and pharmaceutical scientists to screen variable molecular characteristics for optimum and consistent performances, a requirement becoming increasingly important for excipients, and gives opportunities for quality-by-design developments, customized specifications and greater differentiation of the final formulations.
The safety and efficacy of KiOmedine-CsU® was proven in different formulations and therapeutic strategies, such as nanoparticles, tubes and fibres, osteocartilage scaffolds, hydrogel microbeadsand surgical devices. In a recent publication, low molecular weight KiOmedine-CsU® was proved to be the most suitable to prepare siRNA/chitosan polyplexes that achieved fast cellular uptake kinetics and appropriate size and shape.
The availability of KiOmedine-CsU® with unique features is triggering new developments of chitosan-based pharmaceutical and medical device applications beyond topical and haemostatic use. It makes it easier to bring a product on the market thanks to a 100% animal-free process and outstanding consistent characteristics. KiOmedine® undeniably injects the right solution for safe innovations and better developments into the medical and pharmaceutical business.
