BioVaxys Cancer Vaccine Manufacturing Partner Bio Elpida Reaches Bioproduction Milestone
Tuesday, 21 September 2021 10:19.AM
BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys"), announced today that cancer vaccine manufacturing partner Bio Elpida in Lyon, France, has reached major milestones in the development of the bioproduction process for BVX-0918A, BioVaxys' ovarian cancer vaccine and is beginning the next phase of manufacturing process development.
Bio Elpida has completed the technology process transfer with BioVaxys and started the development phase using a Quality by Design ("QbD") approach which includes establishing the control methods and manufacturing process development. In parallel, as Bio Elpida further prepares for GMP manufacturing of BVX-0918A, the preparation of the new manufacturing facility is ongoing and on schedule. The next step is the vaccine process validation using donated tumor samples obtained following surgical excision from ovarian cancer patients.
Bio Elpida President Gilles Devillers says that "This major step is essentially a 'dry-run' for manufacturing the vaccine and preparation for GMP production. Although there is significant know-how required to produce a GLP process that has been contributed by both BioVaxys and Bio Elpida, production of GMP-grade vaccine is about validation, proving sterility, quality control, etc., which must all be extremely well documented for regulatory authorities."
BVX-0918A is headed for a planned Phase I clinical trial in Spain early next year with BioVaxys' EU commercial partner Procare Health Iberia.
BioVaxys President and Chief Operating Officer Ken Kovan stated, "Today's news represents a significant manufacturing milestone for BioVaxys and follows on the back of the news earlier this week that our CDMO partner WuXi Biologics has completed the synthesis of recombinant SARS-CoV-2 s-protein for our BVX-0320 and CoviDTH programs, further demonstrating the outstanding strength of our bioproduction partners while serving as a testimony to the operational and executional capacity of BioVaxys."
SOURCE: BioVaxys Technology Corp.