BioVaxys Technology Corp has successfully completed a sterile and bacteria-free test-run production of its ovarian cancer vaccine BVX-0918, using a cancer patient’s ovarian tumor.
The complete manufacturing of BVX-0918 from an ovarian tumor validates the company’s production protocols for the successful extraction of tumor cells, the cryo-packaging and cryo-preservation of tumor cells and the identification of ovarian cancer cells as the components of the vaccine using specially developed monoclonal antibodies, among others, the company said.
These protocols have reduced the time needed to haptenize the tumor cells by 50%, having established a semi-automatic technique for mechanically extracting tumor cells from a tumor mass, resulting in time savings.
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BioVaxys President and Chief Operating Officer Kenneth Kovan said: "BioVaxys has successfully met a major manufacturing milestone by establishing the process to take surgically excise ovarian cancer cells from a cancer patient, conjugate two haptens, and manufacture a sterile and bacteria-free complete vaccine,” said chief operating officer Kenneth Kovan.
“The next steps now involve GMP product characterization and applying analytical methods to validate that each step of BVX-0918 production is under GMP conditions to the satisfaction of EU regulatory authorities.”
Based in Vancouver, BioVaxys Technology is an early-stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.
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