Delivering Advanced Therapeutics
SUPERCRITICAL CO2 HAS NO EFFECT ON PROTEIN STRUCTURE
Supercritical CO2 has no effect on protein structure
Critical Pharmaceuticals today announced the completion of a series of pre-clinical studies investigating the effect of supercritical CO2 on a therapeutically relevant protein – human growth hormone (hGH). The work, carried out in collaboration with scientists at the University of Nottingham, was the most comprehensive analytical study ever carried out, and proved that protein drugs remain stable when formulated using supercritical CO2.
Dr Andy Lewis, Head of Formulation Development at Critical Pharmaceuticals said, “In the past we have carried out a wide range of analytical tests to show that protein drugs do not degrade and remain active after being formulated using our supercritical CO2 technology. However there always remained the possibility that the techniques we were using were not sensitive to small changes in structure. Using the world class analytical facilities at the University of Nottingham we were able to apply a range of state of the art analytical techniques to study the effect of our process on the protein”
Prof Steve Howdle of the University of Nottingham and founder of Critical Pharmaceuticals also added “We found absolutely no effect of our supercritical process on hGH structure, and the formulated drug was then shown to be 100% active. The data we have collected will be essential to convince the regulatory agencies that our process is safe, and we are now confident in progressing our lead product through pre-clinical testing.”