Lyophilization Development

lyophilization development Clinical Scale and Scale Up Development – Coldstream Laboratories uses both a LyoStar™II and a newly added 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.

Our development team oversees the scale-up of any process developed in our laboratories to ensure a seamless transition from lab-scale to manufacturing. Our formulation experts work first-hand with the Coldstream production team to effect a smooth and efficient transition to plant-scale operation.

LyoStar™3 Capabilities:

The LyoStar™3 R&D lyophilizer substantially reduces cycle development time with advanced technology to deliver accurate and reliable results. Additionally, Coldstream's lab scale LyoStar™3 is equipped with a sample extractor to rapidly and safely remove samples during freeze drying without disturbing the lyocycle.

LyoStar™II Capabilities:

Coldstream's LyoStar™II uses SMART Freeze-Dryer technology to quickly and efficiently develop lyophilization cycles. This technology eliminates the need for a trial and error approach and minimizes issues when transferring to the production scale. The LyoStar™II provides instant data results, such as product resistance, heat flow and mass transfer.

Serum Bottle Capacity (Number of Bottles Processed):

LyoStar™II
Vial Size Full Load
2 mL 1,872
3.5 mL 1,337
5 mL 819
10 mL 684
20 mL 405
30 mL 200
50 mL 132
100 mL 90

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