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What is ControLyo® Technology?

 

Controlled nucleation is becoming 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.

 




How Does ControLyo® Work?

Controlled Nucleation vs Uncontrolled Nucleation

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Controlled Nucleation in Syringes using ControLyo® Nucleation Technology

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The Benefits of ControLyo®

 

ControLyo® is a novel, patent-pending 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 DryingFigure1
  • Reduced freezing stress on biologicals
  • Reduced reconstitution times
  • Drying time optimization
  • Improved cake appearance
  • Reduced protein aggregations

Implementation is a simple 5 step process:

  1. Load containers and seal freeze-dryer
  2. Pressurize with inert gas
  3. Cool shelf and containers to target nucleation temperature
  4. Depressurize to induce nucleation
  5. 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.

 

FAQs

 

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Research and Publications

  • Awotwe-Otoo, D., Agarabi, C., Read, E., Lute, S., & Borson, K. (2013). Impact of controlled ice nucleation on process performance and quality attributes of a lyophilized monoclonal antibody.International Journal of Pharmaceutics, 450 (1-2), 70–78.
  • Siew, PhD, A. (2013). Controlling Ice Nucleation During the Freezing Step of Lyophilization.Pharmaceutical Technology, 37(5), 36-40.
  • Awotwe-Otoo, D., Agarabi, C., Read, E., Lute, S., & Borson, K. (2015). Product and process understanding to relate the effect of freezing method on glycation and aggregation of lyophilized monoclonal antibody formulations. International Journal of Pharmaceutics, 490(1-2), 341–350.
  • SP Scientific. (n.d.). ControLyo™ Nucleation On-Demand Technology Moving from the Lab to Production: A Case Study. 1-9.
  • SP Scientific. (n.d.). Using SMART™ Freeze Drying Technology to Understand the Impact of Controlled Nucleation Temperature on Product Resistance. 1-6.
  • Luoma, J., Lippincott, F., Pawelko, D., Dern, C., Jagannathan, S., Silfies, R., . . . Mather, L. (n.d.). Controlled Ice Nucleation in Production Scale GMP Lyophilizer. [PowerPoint Presentation].
  • SP Scientific. (2013). AAIPharma and SP Scientific enter into supply agreement for Lyophilizers with ControLyo Nucleation On-Demand Technology [Press Release].
  • Tanaka, K., Mudhivarthi, V., Bogner, R., & Pikal, M. (2012). Effect of Controlled Ice Nucleation on Protein Product Quality [Poster].