ControLyo® Nucleation Technology
Welcome to state-of-the-art controlled nucleation technology, ControLyo® – one of the advanced Line of Sight™ lyophilization technologies & PAT tools. Complimenting your existing freeze-drying workflow, ControLyo freezes all vials uniformly and consistently, for superior quality and unparalleled product uniformity.
- Dry faster - reduce primary drying time by 3% for every 1 ˚C increase in nucleation temperature
- Eliminate freezing stress - reduce protein aggregations for better stability of protein formulations
- Reproduce results with ease - replicate from one freeze dryer to another, enabling more efficient scale-up
At SP, we understand the need for trusted process analytical technologies that streamline your drug commercialization process through efficient lyophilization. To meet the growing demand for lyophilized biologics, we offer ControLyo®, a novel, patented freeze-drying technology with instant controlled nucleation for the ultimate product uniformity.
Heterogeneous ice nucleation (crystallization) is one of the biggest challenges in the lyophilization scale-up process. In the absence of controlled nucleation, freezing leads to the formation of random ice crystals, resulting in inconsistent pore sizes, inter- and intra-batch variability, and longer primary drying cycles; all of which negatively impact product quality. The Line of Sight™ ControLyo® Technology gives you control of the nucleation process enabling nucleation at your desired time and temperature, thereby transforming the process from a passive to a controlled event, so you can reproduce with confidence.
- Drug Development
Features & Benefits
- Improved cake appearance and morphology; no visible collapse or shrinkage thanks to an increase in cake pore size and subsequent reduction in dry layer resistance
- Conforms to the regulatory framework required for Quality by Design (QbD) by controlling process inputs
- Unlike other similar technologies, ControLyo does not require a formulation change or the introduction of foreign material
- No need to purchase additional freeze-drying equipment and retrofits into most existing commercial dryers