BIOAVAILABILITY IMPROVEMENT: SUPER CRITICAL FLUID ATOMIZATION PLANT RECEIVES SWISSMEDIC AUTHORIZATION FOR GMP PRODUCTION
We announce with pleasure that Cerbios-Pharma SA (from now on CERBIOS) 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.
Cerbios is a privately held company located in Lugano, Switzerland, that specializes in the development and manufacture of both chemical and biological APIs for its partners world-wide.
Exclusive, third-party manufacturing services are offered by the Chemical Division for HPAIs and by the Biological Division for monoclonal antibodies, recombinant proteins and pharma probiotics.
Cerbios provides full CMC support to its world-wide partners, including the supply of cGMP clinical batches, registration/validation material and commercially manufactured APIs. Paramount to this is the ability to supply all of the technical documentation and support necessary for a successful registration. Cerbios’ commercial products are marketed worldwide but primarily in Europe, USA, Japan and India.