Nucleation technology and the freeze drying process

SP Scientific has purchased ControLyo Nucleation Technology and all related patents from Praxair Inc. ControLyo nucleation technology controls the freezing stage of the freeze drying process for more consistent and repeatable outcomes that aid drug development, scale-up and production efforts. SP which manufactures a full range of research through production lyophilization equipment and technologies has had a licensing agreement with Praxair, Inc. to provide ControLyo technology as part of its portfolio since 2010.

In making the announcement, Bill Downs, President and CEO of SP noted that moving from licensing to ownership “will allow SP Scientific to work more closely with our customers and leading freeze drying scientists to continually advance the commercial benefits, and drive adoption and integration of ControLyo™ technology with ancillary technologies offered by SP Scientific.”

In traditional 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. ControLyo technology, utilises pressurisation to induce nucleation while maintaining the temperature to within 1 °C of a product’s freezing point and at the same time minimises the supercooling effect.  This produces lowered product resistance with resulting benefits that include improved product uniformity, quality and yield, and a reduction of cycle times by as much as 40%. In contrast to other controlled nucleation methodologies, the 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 lyophilization process.

Applicable to research and development, pilot and production freeze dryers, SP Scientific has implemented ControLyo technology on their LyoStar3 freeze dryer systems worldwide as well as new and retrofit installations on existing SP and competitor production freeze dryers. Demand for this technology is expected to increase as the pharmaceutical industry continues its quest for robust and proven lyophilization processes in order to bring their products to market efficiently and safely.

Downs commented: "Controlling the freezing step utilising ControLyo technology offers researchers a valuable, time-saving tool for optimising cycle development using methodologies that are easily scaled-up, allow repeatability and adhere to a QbD manufacturing approach. The technology is particularly valuable for optimisation of freeze-drying cycles for new drug product formulations that include proteins, vaccines and small molecules.”

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