Kane Biotech’s topical wound spray DispersinB has passed all required quality control (QC) tests, including the sterility test, after a 12.5-week accelerated shelf-life study at 25 degrees C and 60 RH (Relative Humidity), which is equivalent to a shelf-life of one year at 4 degrees C.
The DispersinB topical wound spray was manufactured by Therapure Biopharma (Mississauga, ON, Canada), under current Good Manufacturing Practices (cGMP).
DispersinB is an antibiofilm enzyme, which inhibits and disperses biofilms of major bacterial pathogens. It was discovered by Jeffrey Kaplan, Department of Oral Microbiology, New Jersey Dental School, NJ, US.
Kane Biotech vice president-Research and chief scientific officer Sri Madhyastha said that in addition to QC testing, they have also confirmed the biological activity of the DispersinB topical wound spray finished product based on its ability to prevent and remove bacterial biofilms using a standard biofilm assay.
“The 12-month real-time shelf-life study on the wound spray at 4 degrees C, is currently in progress, Madhyastha said.
Kane Biotech president and CEO Gord Froehlich said that the successful formulation and manufacturing of a topical wound spray for human clinical trials is an important step in developing wound care products for the treatment of patients suffering from chronic and poorly healing wounds.
“Once the currently on-going biocompatibility studies on DispersinB topical wound spray are completed, we plan to prepare the IDE (Investigational Device Exemption) regulatory package for submission to the FDA,” Froehlich said.