Our Sterile Injectable facility, Coldstream Laboratories, located in Lexington, KY USA assists customers in all stages from lyophilization development and optimization through manufacture of clinical trial materials and niche commercial products.
- Clinical Scale and Scale Up Development
- We use a LyoStar™II and a LyoStar™3 R&D freeze dryer to develop lyophilized formulations that are based on robust and cost-efficient processes.
- Our rapid-response formulation team has experience in screening effective combinations of solvents (both aqueous and non-aqueous), buffers, bulking agents, and lyo/cryo-protectants. This experience leads to a robust final product that has low residual moisture/solvent, forms a solid and attractive cake, reconstitutes readily and completely, and resists physical and chemical degradation.
- Using our lab-scale freeze dryers, Coldstream Laboratories’ formulation team develops compounding processes and lyophilization cycles that can be successfully and readily transferred to our cGMP production scale freeze dryer.
- cGMP Production
- Clinical scale production of lyophilized products centres around the 48 square foot Hull lyophilizer within our sterile manufacturing facility.
- Our freeze dryer is fully integrated with the state-of-the-art, isolator-based automated filling lines .The lyophilizer chamber can accommodate up to 15,000 units per cycle depending on vial size.
- Hull Capabilities:
- Serum Vial Capacity (Number of Vials Processed)
Vial Size Approximate Full Load 3 mL 15,000 5 mL 9,000 10 mL 7,500 20 mL 4,500 30 mL 3,200 50 mL 2,300