Edition 1 / September 2018
CordenPharma’s Injectables Platform offers global customers a full & balanced range of injectable services, including the capability for “combining” injectable drugs with devices (recently defined by the FDA as “Combination Products”). Our Injectable manufacturing covers both Terminal Sterilization and Aseptic Filling Technologies for Pre-filled Syringes (PFS), Vials, Ampoules and Lyophilized Vials, with a wide range of filling volumes (Aseptic from 0.5 to 10 ml; Terminally Sterilized from 5 to 100 ml). With multiple process and filling lines and an overall annual capacity of ~100 million units, the CordenPharma Injectables Platform offers the flexibility to support multiple programs and customers (> 110 markets) in parallel, at any scale and stage of drug development.
The newly constructed commercial aseptic fill and finish plant at CordenPharma Caponago (IT), which consists of two highly flexible filling lines allowing the manufacture of a broad range of vials, Pre-filled Syringes and cartridges by using state-of-the-art nest & tub technology, remains on track for completion in 2018. One of the new lines is already operational, with a successful PAI FDA inspection completed in July 2018 for two products, which will increase the manufacturing capacity up to 20 million vials per year, along with pre-filled syringes and additional lyophilization capacity.
In addition to disposable / single-use injectable technologies, CordenPharma Caponago is well equipped to handle compounds which are prone to oxidation through its state-of-the-art compounding system, where traditional stainless steel mixing vessels and usual transfer lines cannot be adopted. All aseptic processing lines are compatible for ready-to-fill nest & tub materials. CordenPharma’s customers benefit from our Integrated Supply solutions, which span from sourcing to the development and manufacturing of APIs and Drug Products, providing a time and cost saving path to easier injectable product filling. In particular, our expertise in the development and manufacturing of Peptides, Lipids & Carbohydrate APIs brings reduced complexity, de-risked supply chain and shorter lead-times enabling CordenPharma’s customers faster time to market for both clinical and commercial supply to patients.
Last but not least, all finished dosage facilities at CordenPharma Caponago meet the serialization compliance requirements to combat global counterfeiting. In addition, a global serialization team was established to standardize processes & logistics and maintain the integrity of the data. All CordenPharma facilities are routinely inspected by major regulatory compliance agencies and regularly supply to all regulated markets worldwide.
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