In our last newsletter, we shared that the acquisition of bioproduction partner Polyplus/BioElpida by Sartorius Stedim Biotech enables BioVaxys to tap into expanded service offerings, technical abilities, and enhanced production scalability for clinical trial and commercial supplies. This is a very exciting development for BioVaxys as we will tap into these augmented capabilities for BVX-0918.
At the end of last year, BioVaxys/BioElpida performed a successful sterile, bacteria-free, test-run production of BVX-0918. This validated the vaccine production process starting from a cancer patient’s ovarian tumor, including extraction of tumor cells, the cryo-packaging and cryo-preservation of tumor cells, identification of ovarian cancer cells as the components of the vaccine using specially developed monoclonal antibodies and flow cytometry, sterility processes, and development of the process for double haptenization of the ovarian tumor cells used in the vaccine.
What we now have is the process that could be used to create a sterile vaccine to treat a patient---provided that was permitted by regulatory authorities. Remaining manufacturing efforts over the next few months are now mostly advancing GMP process development, QC, controls, and validation necessary for a regulatory filing for the Phase I study in Spain. This includes QC validation of control methods for GMP testing, GMP qualification of equipment for aseptic production and packaging, raw materials suppliers qualification, GMP documentation creation, final product engineering batch qualification, cleaning verifications.
Together with our EU partner, Procare Health, we have lined up the principal investigators and respective study centers in Spain for the Phase I study, and has selected the CRO to manage the trial and conduct data analysis. |
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