Consort Medical has announced a range of facility upgrades for manufacturing and packaging solutions at the Aesica production plants in Pianezza, Italy, and in Monheim, Germany.
A British CDMO with a global footprint, Consort is the parent company of Aesica, a specialist in both APIs and finished dose forms, and Bespak, a drug delivery device manufacturer.
Clinical and commercial fill-finish capabilities for pre-filled syringes are being established at the Aesica site. The investment comprises a redesigned oral liquids facility featuring the latest Marchesini equipment. Consort said the Pianezza site will double the production capacity of oral formulated drugs to 28 million bottles per year.
The facility has been further equipped with new dissolution equipment to allow the production of a wider variety of oral solutions, including emulsions. The line is fully serialisation-ready and equipped with a unique process monitoring system to support efficiency and quality.
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 programmes, the company explained in a statement.
"Offering both development/clinical and commercial prefilled syringe capabilities will allow customers 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."
Qualification and validation activities will be taking place during Q4 2018 and, following receipt of the necessary local authorisations, the facility will be ready to start production in Q1 2019 for clinical development. The infrastructure for commercial capabilities will be operative by the end of 2020.
Consort has also said it is investing in new double row blister and carton packaging line at its site in Monheim, Germany. The upgrade has been designed by Uhlmann, the German equipment manufacturer.
The enhanced capability will come online in Q1 2019, following qualification, validation and receipt of regulatory approvals.
The blister line will consist of a fully automated serialisation station as well as an online integrated case packer.
The machine has a capacity of up to 500 blisters and 300 boxes per minute and can blister all common materials, i.e. alumina, PVC and PP. Blister filling is checked by an optical camera system and can be printed online with artwork.
“Ensuring high standards of quality and efficiency are key elements in our delivery of Industry 4.0,” commented Manja Boerman, President Aesica CDMO Services, Consort Medical.
“Our serialisation technology is delivering full GMP-compliance for the European market, addressing anti-counterfeiting and fraud. Equipping our production lines with fully integrated serialisation solutions and the latest process monitoring technologies are crucial," Boerman concluded.