A NATURAL PROCESS FROM EDIBLE WHITE MUSHROOM
Chitosan is a bioresorbable cationic biopolymer made of D-glucosamine and N-acetyl-D-glucosamine.
Ultrapure chitosan is the endotoxin-free chitosan manufactured in accordance with cGMP, suitable for injectable formulations and implantable devices.
UNIQUE CUSTOMIZABLE 100% ANIMAL-FREE ULTRAPURE CHITOSAN
KIOmed Pharma has an exclusive license on the exploitation of KitoZyme’s patent, that discloses the process of manufacturing chitosan from fungal sources. The raw material used by KIOmed Pharma is the Agaricus Bisporus, the white edible mushroom available from industrial mushroom growers tat gives access to chitosan with excellent purity and tunable molecular weight.
A key aspect of this technology is the control of the complete production process from the mushrooms to final packaging. The use of this particular mushroom enables traceability and reproducibility and ensures a high consistency in the chitin and chitosan output.
ISO13485 CERTIFIED cGMP MANUFACTURING CLEANROOMS
The new manufacturing facility consists of 160-m2 Class C cleanrooms meeting the ISO14644 and European current Good Manufacturing Practice (Eudralex Volume 4, Appendix 1) standards for cleanroom classification.