Cerbios-Pharma SA has successfully passed the SwissMedic cGMP inspection for the new Super Critical CO2 atomization plant with only a couple of recommendations.
The investment announced in March 2015 (see link) is now in full operation and the authorization received covers both clinical and commercial supply.
“The Cerbios’ team has performed excellent work in the installation and qualification of this new and innovative equipment and I am very proud of them”, confirms Gabriel Haering, CEO.
“The narrow particle size distribution, combined with the possibility of particle size fine-tuning down to nanoparticles will help to improve the use of APIs that have poor aqueous solubility, providing improved solubility. “
This is the major challenge for the New Chemical Entities under development as drug candidates for the pharmaceutical industry.”
In fact, the possibility of using APIs of submicron crystals is an attractive solution to improve the bioavailability of poorly soluble drugs, providing therefore, improved therapies with lower dosages and fewer side effects.
A video showing the plant in operations is also available at this link.