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BioVaxys cancer vaccine manufacturing partner Bio Elpida reaches bioproduction milestone BioVaxys cancer vaccine manufacturing partner Bio Elpida reaches bioproduction milestone Bio Elpida has completed the technology process transfer with BioVaxys and started the development phase using a ‘quality by design’ approach, which includes establishing the control methods and manufacturing process development Bio Elpida has completed the technology process transfer with BioVaxys and started the development phase using a ‘quality by design’ approach, which includes establishing the control methods and manufacturing process development (, ) announced that cancer vaccine manufacturing partner Bio Elpida has reached major milestones in the development of the bioproduction process for BVX-0918A, BioVaxys’ ovarian cancer vaccine. The Lyon, France-based company is now beginning the next phase of manufacturing process development. (, ) announced that cancer vaccine manufacturing partner Bio Elpida has reached major milestones in the development of the bioproduction process for BVX-0918A, BioVaxys’ ovarian cancer vaccine. The Lyon, France-based company is now beginning the next phase of manufacturing process development. Vancouver-based BioVaxys said Bio Elpida has completed the technology process transfer with BioVaxys and started the development phase using a ‘quality by design’ approach. which includes establishing the control methods and manufacturing process development. Vancouver-based BioVaxys said Bio Elpida has completed the technology process transfer with BioVaxys and started the development phase using a ‘quality by design’ approach. which includes establishing the control methods and manufacturing process development. In parallel, as Bio Elpida further prepares for GMP (good manufacturing practice) 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. READ: BioVaxys says partner completed synthesis of recombinant SARS-CoV-2 s-protein for its BVX-0320 and CoviDTH programs In parallel, as Bio Elpida further prepares for GMP (good manufacturing practice) 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. READ: BioVaxys says partner completed synthesis of recombinant SARS-CoV-2 s-protein for its BVX-0320 and CoviDTH programs “This major step is essentially a ‘dry-run’ for manufacturing the vaccine and preparation for GMP production,” Bio Elpida president Gilles Devillers said in a statement. “This major step is essentially a ‘dry-run’ for manufacturing the vaccine and preparation for GMP production,” Bio Elpida president Gilles Devillers said in a statement. “Although there is significant know-how required to produce a GLP (good laboratory practice) 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.” “Although there is significant know-how required to produce a GLP (good laboratory practice) 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.” BioVaxys said BVX-0918A is headed for a planned Phase I clinical trial in Spain early next year with its EU commercial partner, Procare Health Iberia. BioVaxys said BVX-0918A is headed for a planned Phase I clinical trial in Spain early next year with its EU commercial partner, Procare Health Iberia. “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,” BioVaxys President and Chief Operating Officer Ken Kovan said. “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,” BioVaxys President and Chief Operating Officer Ken Kovan said. BioVaxys is a clinical-stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics. BioVaxys is a clinical-stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.
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