A proven, comprehensive approach to long-term product stability, lyophilization is an increasingly important step for many of today’s complex, sensitive biologics. Learn how we implement, customize, and manage this process for vial-based injectable therapies.
For lyophilization, customization is key. Every freeze-drying cycle we develop is expertly customized for a specific product and its unique molecular properties – as well as its up- and downstream manufacturing processes.
That tailoring begins with process development and characterization steps carried out with a small-scale laboratory freeze-dryer and small API samples, before scaling to commercial production following qualification and validation. During that process, we rigorously test a wide range of thermal product properties, process/equipment parameters, and packaging factors to identify the optimal temperature, pressure, and batch size for each molecule.
After filling and lyophilization, every vial must pass through our 100% visual inspection process. Like every product unit we produce, lyophilized vials are only approved for release once we have visually verified that they meet both our customer’s exact requirements and the strict regulatory specifications for each product’s market.
We offer expert lyophilization support at every stage of an injectable product’s life cycle in a vial: from lab-scale freeze drying for initial studies and batches, to commercial-scale lyophilization for global market supply.
Each of our manufacturing facility is equipped with freeze drying capabilities.
Clinical manufacturing: Our Chicago facility features two Class 100 aseptic filling lines with a manually loaded lyophilizer, while our Rankweil site features one Class 100 aseptic filling line with a fully integrated, automatically loaded lyophilizer.
Commercial manufacturing: All of our three world-class manufacturing sites offers commercial-scale lyophilization services for injectable therapies.
