News & Press
Drug Development & Delivery, May 2019
The emergence of disposable/single-use-system injectable technologies provides alternatives to traditional compounding-filling in stainless steel devices. State-of-the-art compounding-filling suites handle compounds that are prone to oxidation or are not compatible with standard contact material, where traditional stainless steel mixing vessels and usual transfer lines cannot be adopted.
“Options in compounding-filling technology allow the customer to have the best “compatibility” set-up, as well as receive a good range of batch sizes to be driven into their targeted container,” says Fabio Stevanon, Director, Global Injectables Platform, CordenPharma International.
CordenPharma also focuses on the importance of flexibility for clients to make the best choice in using either glass or plastic cyclo-olephins containers, and to cope with specific requirements connected to their formulation where non-ionic – no-metal release is needed, or non-polar contact surface is required. “The ability to utilize traditional or fully-disposable compounding systems, coupled with a range of containers with various material compatibility, expands the concept of flexibility for customers facing specific formulation requirements,” Mr. Stevanon says.
CordenPharma’s Injectables Platform offers customers a range of injectable services. Its injectable manufacturing capability covers both terminal sterilization and aseptic filling technologies for PFS, vials, ampoules, and lyophilized vials, with a range of filling volumes (aseptic from 0.5 to 10ml; terminally sterilized from 5 to 100ml). “With multiple process and filling lines, and an overall annual capacity of ~100 million units, the platform offers the flexibility to support multiple programs and customers in parallel, at any scale and stage of drug development and commercialization,” says Mr. Stevanon.
The Italy-based injectable facility, CordenPharma Caponago, has two flexible injectable filling lines: One line that manages 1 to 10ml PFS and 3ml cartridges had successful FDA and EU inspections in 2018; and the second line – which focuses on both liquid and lyo vials in ranges from 1 to 10ml – will be validated this spring and approved by the end of the year.