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CERBIOS further invests in its High Potency APIs manufacturing capacity

January 14 2019

Cerbios-Pharma SA (from now on “Cerbios”) board of directors has approved the detailed design and budget for the installation in its High Potency Active Ingredients (HPAIs) dedicated building of a new production line able to accommodate larger volumes and batch size.

Cerbios is active in the HPAI arena since 1993 with an established expertise on handling Category 4 SafeBridge (OEL<10 ng/m3) Drug Substances in four different lines: 2 non cGMP ; 2 cGMP.
The P5 building for larger scale cGMP production of HPAIs was originally conceived with empty spaces available for installing an additional production line.

The new production line will be Category 3 SafeBridge for batches ranging 5-30 kgs/ batch.
The new unit will be partially occupied for the manufacturing of an HPAI where larger volumes are required thus decreasing the production costs compared to the actual setup. The remaining capacity will be available for our CDMO services and partners.

“With 25 years of experience handling HPAIs, Cerbios’ reputation for its know-how and proficiency is bringing an increased number of partners’ projects for the development and manufacturing of clinical material as well as commercial production“,  confirms Dr. Gabriel Haering, CEO. “Considering the conjugation suite for Antibody Drug Conjugates ready this summer and this new production line due in the second half of 2020, our offer to our partners will be six HPAI production units in a single site with space available for future expansions if needed”.

In fact, Cerbios supports its partners from the production of non cGMP batches needed for preclinical tests, through clinical to commercial supply applying state-of-the-art Project management system and Quality by Design approach that are paramount to the success of a production campaign and process evolution beyond the registration phase.

About Cerbios-Pharma SA

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.
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