Validation of the ZENEO® Midazolam clinical batch from our partner Crossject

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).

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.

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.

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.

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.

The Group is thus positioning itself as the preferred CDMO for innovative biotechs.