ControLyo® Nucleation Technology

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
• Production/Manufacturing

• 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

• ControLyo® Nucleation Technology
• http://Evaluating-the-Impact-of-Controlled-Nucleation-Dr-Amy-Bosch
• http://SP-Hull-White-Paper-Line-of-Sight