BioVaxys announced that its bioproduction partner Bio Elpida of Lyon, France, has initiated the construction of a new Good Manufacturing Practice ("GMP") cleanroom facility needed for producing the clinical supply of BVX-0918A, BioVaxys' ovarian cancer vaccine candidate. The design, construction and qualification of the new facility will be dedicated to autologous cancer vaccine production for BioVaxys, allowing for ovarian tumor biopsy reception and treatment within a short time frame. The GMP cleanroom facility is planned to be completed by the end of this year.
The bioproduction process development consists of two phases. The first phase, which has begun, is a feasibility study and involves the development of production techniques using BioVaxys know-how. After establishing these techniques, Bio Elpida will further develop the required procedures, tests and assays over the next few months so that the product can be produced in compliance with GMP requirements.
Bio Elpida will work with BioVaxys to prepare the manufacturing section of the Clinical Trial Application (the "CTA," which is similar to the US IND application) for the EU. Upon acceptance of the CTA, the second phase of the engagement would then commence, which is the manufacturing and testing of clinical samples for administration to patients as part of the EU clinical trial phase I/II planned for Q2 next year.
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