Hemosol said that it began initial production of its first bloodsubstitute product last week at its plant in Etobicoke, Ontario.
Production began following the first stage of expansion of thefacilities, which includes additional containment and cleanrooms, increased production areas and the installation ofequipment and utilities for higher-volume production, thecompany said.
Hemosol of Toronto said it expects to file an investigational newdrug application with the U.S. FDA and a preclinical new drugsubmission with the Health Protection Branch, Health andWelfare Canada late this year. The company intends to beginhuman trials early next year, and market introduction istargeted for 1996.
Hemosol's proprietary and licensed technologies involve theseparation of hemoglobin from red blood cells and thecontrolled chemical modification of the purified hemoglobinusing a process to modify the oxygen-binding and deliveryproperties of hemoglobin to those similar to whole red bloodcells.
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