ARTICLE
Controlled nucleation is now an important step in a freeze drying cycle and our development work with ControLyo® Technology has shown significant benefits.
Its function is to control the nucleation of the product solution in the freeze dryer, i.e. the solution in all vials (or bulk, syringes, etc.) allowing nucleation at the same time and the same temperature, which is predefined by the researcher.
This is key to reducing cycle times and providing a cycle design which can be reproduced from one freeze dryer to another. In short, ControLyo® Technology delivers a controlled process, improves product quality, shortens drying times, and requires no formulation change or introduction of foreign material into the vials.
The Benefits of ControLyo®
ControLyo® is a novel, patented approach to uniformly and instantaneously induces nucleation within a freeze-dryer via pressurization and depressurization.
- Increase in cake pore size and subsequent reduction in dry layer resistance
- Faster Primary Drying
- Reduced freezing stress on biologicals
- Reduced reconstitution times
- Drying time optimization
- Improved cake appearance
- Reduced protein aggregations
Implementation is a simple 5 step process:
- Load containers and seal freeze-dryer
- Pressurize with inert gas
- Cool shelf and containers to target nucleation temperature
- Depressurize to induce nucleation
- Maintain shelf setpoint at the ice nucleation temperature until the ice is fully formed
- Reduce shelf temperature to complete freezing
For widespread adoption, the technology must be scalable and ideally can be retrofit to existing production dryers. Our work shows that it is both scalable and generally quite easy to retrofit most existing commercial dryers with ControLyo® Technology. From the level of interest in and evaluation of dryers for retrofit, we see this technology being rapidly adopted by the industry.
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