Controlled lyophilization nucleation system for drug development
During the lyophilization scale-up process in drug development, uncontrolled ice nucleation can lead to inconsistent product quality. This often results in inter- and intra-batch variability, as well as longer primary drying cycles, all of which negatively impact the final product.
Enhances nucleation control and product uniformity
The ControLyo® Nucleation Technology from Sp Scientific is a patented freeze-drying technology designed to provide instant and controlled nucleation. This technology allows for nucleation at a specified time and temperature, ensuring uniform ice crystal formation. By implementing this technology, you can achieve consistent pore sizes and reduce variability within and between batches. Additionally, the technology reduces primary drying time by 3% for every 1 ˚C increase in nucleation temperature. It also minimizes protein aggregations, thereby enhancing the stability of protein formulations. The ControLyo® system can be easily integrated into existing freeze dryers without the need for formulation changes or additional freeze-drying equipment.
Benefits
- Improves product uniformity and quality
- Reduces primary drying time by up to 3% per 1 ˚C
- Minimizes protein aggregations for better stability
- Retrofits into existing freeze dryers without additional equipment
- Eliminates the need for formulation changes or foreign materials