SP Scientific (SP – Warminster, PA) has purchased ControLyo™
Nucleation Technology and all related patents from Praxair Inc. (Danbury,
CT). 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, 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 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 utilizing ControLyo™ technology offers researchers
a valuable, time-saving tool for optimizing cycle development using
methodologies that are easily scaled-up, allow repeatability and adhere to a
QbD manufacturing approach. The technology is particularly valuable for
optimization of freeze-drying cycles for new drug product formulations that
include proteins, vaccines and small molecules.”
For further information on ControLyo™
technology please visit www.spscientific.com
or contact SP Scientific Sales at +1-845-255-5000 / sales@spscientific.com.