Lyophilized Products

cGMP Production

Clinical scale production of lyophilized products centers around the 48 square foot Hull lyophilizer within the sterile manufacturing facility. Our freeze dryer is fully integrated with the state-of-the-art, isolator-based automated filling line. The lyophilizer chamber can accommodate up to 15,000 units per cycle depending on vial size.

Our experienced development and production staffs are intimately familiar with the capabilities of the lyophilizer and can work with clients and Coldstream development personnel to adapt processes to our facility.

Hull Capabilities:

Serum Bottle Capacity (Number of Bottles 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

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