Ensuring robust lyophilization scale-up

Presentation provides new data regarding the mechanism of the ControLyo Technology.

In this presentation, Mr Luoma examines the benefits of the technology for high fill-volume configurations and presents new data regarding the mechanism of the ControLyo Technology. The presentation shows how gaining a more complete understanding of the mechanism of nucleation using ControLyo Technology ensures more robust freezing when scaling from the lab to commercial-scale freeze dryers.

Traditionally in lyophilization cycles, the freezing process is uncontrolled because of the random nature of the nucleation or crystal-forming process within individual vials and across vials in a freeze dryer chamber. SP Scientific's proprietary ControLyo technology, utilizes pressurization to induce nucleation while maintaining the temperature to within 1 °C of a product’s freezing point and at the same time minimizes the supercooling effect. This produces lowered product resistance with resulting benefits that include improved product uniformity, quality and yield, and depending on formulation a reduction of cycle times by as much as 40%. In contrast to other controlled nucleation techniques, ControLyo Technology process does not introduce any foreign elements which could potentially become a carrier for micro-organisms being introduced into the product vials during the freezing process.

Jacob (Jake) Luoma has been an engineer at Genentech since 2012. After he graduated from the University of Colorado Boulder with a BS in Chemical and Biological Engineering, he joined the Genentech Process Development Rotation Program. Jake then joined the Pharmaceutical Processing and Technology Development group. There, he works on a team which develops pharmaceutical drug product manufacturing processes and technologies on the pilot scale and conducts technology transfers to implement on the manufacturing scale.