BioVectra has completed the manufacturing of DispersinB Topical Wound Gel under current Good Manufacturing Practices (cGMP). The required quality control (QC) tests, including sterility and DispersinB and alginate concentrations, have been completed, said the company.
Sri Madhyastha, vice-president of Research & chief scientific officer of Kane Biotech, said: In addition to QC testing, we have also confirmed the biological activity of the DispersinB Topical Wound Gel finished product based on its ability to inhibit as well as disperse bacterial biofilms using a standard biofilm assay. The real-time shelf life and accelerated aging studies on the wound gel under cGMP are currently in progress.
Gord Froehlich, president and CEO of Kane Biotech, said: The successful manufacturing of DispersinB for human clinical trials is a critical step in the pathway to making a positive impact for patients suffering from chronic and poorly healing wounds. With this step completed, we can now move forward and complete the DispersinB Topical Wound Gel biocompatibility studies and work with our collaborators to design the regulatory approval program.