A new milestone has been reached in the partnership between Cenexi and Crossject, a start-up developing self-administered emergency medication and medical devices with a view to their marketing: compliance of the batch intended for the bioequivalence study on ZENEO® Midazolam 10 mg (for epileptic seizures). Following this production, Cenexi teams at Braine-Alleud will be able to launch the validation batches, a step prior to the Marketing Authorization Application (MAA).
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As a reminder, Crossject has developed a very innovative needle-free injection system, ZENEO®, which has been the subject of over 400 patents. Crossject worked on container filling technology with Cenexi’s Braine-Alleud site (Belgium) due to its recognized expertise in designing sterile processes. The Group therefore supports this laboratory in developing, filling, assembling, and packaging the needle-free auto-injector.
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When the industrial ramp-up stage began in May 2021, the partnership, entered into in 2016, was strengthened with a new agreement synchronizing activities for the industrial production and large scale marketing of this innovative device.
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Thanks to major, complex development phases, another key step has been completed, with the production and validation of the very first clinical batch packaged in ZENEO®. This production was made possible by a new, patented filling process using equipment specifically designed to meet the specific characteristics of the auto-injector components.
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This success supports Cenexi’s strategy to become a long-term industrial partner since it will be in charge of producing the commercial batches and filling ZENEO® with the eight drugs currently used with it.
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The Group is thus positioning itself as the preferred CDMO for innovative biotechs.