Alba has been developed to support new drugs development “from conception to injection”, de-risking any switch from one container to another.
To address the numerous issues linked to biologic drugs, Ompi has developed the EZ-fill® Alba platform which has been devised to support drug development "from conception to injection".
The Alba range comprises a ready-to-use-glass container platform, including vials, cartridges, and syringes, with similar chemical and mechanical characteristics: All the containers show the same contact surface to the drug. This removes the uncertainties associated with new packaging materials when moving from Phase II to Phase III, de-risking the whole development process. The same benefits can be applied to marketed drugs, when the packaging is changed or the drug is put into a different container format.
Moreover, the Alba coating creates a barrier between the drug and the glass that makes it possible to reduce the amount of inorganic extractables significantly by comparison with a standard bulk container.
The strong chemical bond also leads to better stability during the time of functional performance, i.e. gliding and break-loose force. In addition, in vials, Alba coating acts as a barrier against aggressive drugs, preventing delamination.
Since around 50% of particles are normally generated by interaction between the rubber components and the drug, Ompi worked closely with rubber manufacturers: this fundamental collaboration ensured that the same materials were available for all of the Alba platform container formats, i.e. vial stoppers, syringe plungers and cartridge plungers.