At Fresenius Kabi lyophilization has been a well-established technology for some time. Recently, a new small volume parenteral (SVP) filling line with an integrated freeze dryer has been installed at the Graz plant to add capacity for third-party manufacturing. Fresenius Kabi Product Partnering can now offer services in the development and commercial manufacturing of lyophilized products for aqueous and liposomal formulations.
Development of Formulation and Lyophilization Cycle – I&D Graz
- Formulation development
- Development of lyophilization cycle in a small-scale freeze dryer with temperature sensors in vials
- Scaling-up of the lyophilization cycle to a pilot-scale freeze dryer
Commercial manufacture of lyophilized product – Plant Graz
- State-of-the-art aseptic filling line and lyophilization unit, freeze dryers are fully integrated into the aseptic filling line.
- Can work with high-potency and biological APIs
- High-speed SVP line with different dosing systems
- Vials size: 2 to 30 mL