Clinical and commercial fill-finish capabilities for pre-filled syringes are being established at one of the Aesica production sites. Aesica has extensive experience in providing sterile products to the market, through vials and ampoules. The GMP infrastructure and expertise already available for sterile products will be leveraged and enhanced by the installation of the pre-filled syringe line.
The line also creates the possibility to source the finished pre-filled syringe combined with the Bespak Syrina autoinjector device.
The Aesica prefilled syringe and Bespak device capabilities will allow early introduction of the prefilled syringe and/or auto-injector into development programs. Offering both development/clinical and commercial prefilled syringe capabilities will allow customers both to switch from vial to prefilled syringe and/or autoinjectors early in development and subsequently move to commercial scale at the same site, accelerating timelines and lowering overall costs.
Clinical development capabilities will be available in the course of 2019, commercial capabilities by the end of 2020.