SP Scientific is combining its lyophilisation equipment with ControLyo from Praxair to enable precise control over the freeze-drying process.
Praxair developed ControLyo nucleation on-demand technology to give customers more control over the freezing step of lyophilisation. By controlling the nucleation temperature to within one degree Celsius users can improve product uniformity, quality and yield while cutting cycle times.
SP Scientific has licensed the technology, ControLyo, from Praxair. Rich Jarrett, director of business development for Praxair’s biopharm business, said combining the technologies allows drug manufacturers to “consider a variety of formulations during drug and process development”.
Companies sourcing lyophilisation equipment from SP Scientific will have access to “freeze-drying equipment and tools to improve their overall economics and processes”, said Bill Downs, chief operating officer and executive vice president at SP Scientific.
Praxair developed ControLyo to tackle subcooling. When vials undergo the freezing phase of lyophilisation nucleation occurs at a range of temperatures. This phenomenon of a liquid going below its freezing temperature but not solidifying is known as subcooling.
To eliminate the increased drying time, reduced yield and non-uniformity subcooling causes Praxair developed a technology, ControLyo, to manipulate pressure in the chamber during the freezing process.
Furthermore, Praxair says controlling nucleation creates favourable ice structures and reduced concentration gradients, making the process less damaging to sensitive biopharm ingredients.
SP Scientific markets freeze dryers for use at scales ranging from laboratory up to custom-built systems for commercial production. This product range will now be enhanced by the addition of ControLyo which Praxair designed to be easily retrofitted to existing products.