By CERBIOS-PHARMA SA
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SwissMedic authorizes Cerbios SCF Atomization for GMP Production
Lugano, Switzerland: – High-tech CDMO Cerbios-Pharma SA (Cerbios) has announced that the SwissMedic regulatory agency has authorized its new Super Critical Fluid (SCF) Atomization Plant for cGMP production.
Use of SCF technology, to produce nanoparticles of high potent API (HPAI), can significantly increase the bioavailability of Cerbios-manufactured products.
“The plant successfully passed the SwissMedic cGMP inspection for the new Super Critical CO2 atomization plant with only a couple of recommendations,” said Cerbios.
Clinical and commercial authorization
“The authorization received covers both clinical and commercial supply,” the company added.
The new plant, part of the recently constructed state-of the-art Cerbios production facility at Lugano, was first announced in March 2015 and is now in full operation.
“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”, commented Cerbios’ CEO Gabriel Haering.
“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 bioavailability of the same”, Mr. Haering added.
Increasing bioavailability is a key challenge for use of New Chemical Entities (NCEs) under development as drug candidates for the pharmaceutical industry.
It opens up possibilities to use active pharmaceutical ingredients (APIs) based on submicron crystals as an attractive route to improve the bioavailability of poorly soluble drugs to provide improved therapies with lower dosages and reduced side effects.
Cerbios-Pharma SA 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. It specializes in the development and production of high potency active pharmaceutical ingredients (HPAPIs) in the area of fine chemicals and biologicals.
Cerbios Chemical Division offers exclusive, third-party manufacturing services for HPAIs while Biological Division produces monoclonal antibodies, recombinant proteins and pharma probiotics.
Cerbios provides full CMC support to its worldwide 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.