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Cerbios' New Manufacturing Plant Enters Qualification Phase

19.02.2013 -

Cerbios-Pharma has announced that the construction phase for its new biotechnology plant in Barbengo (Switzerland) is almost concluded. The "state-of-the-art" biologics plant is dedicated to the production of monoclonal antibodies or therapeutic recombinant proteins based on a CHO platform under cGMP and authorization by Swissmedic for the production of clinical and commercial batches is planned during Q3 / 2013.

This facility will allow Cerbios to strengthen its position as a contract manufacturer for the production of New Biological Entities (NBE) for clinical studies, while until now Cerbios was only supplying material for toxicological studies.

There was a certain delay in the detailed design phase due to comments and observations received from Swissmedic and from our FDA consultant (former FDA inspector for Biotechnology plants audits) during their preliminary reviews.

"I am not frustrated by this delay" confirms Gabriel Haering, Cerbios' CEO. "This delay will be compensated by the fact that Cerbios will now be able to serve its partners for global projects (EU, USA, JPN) like for all our other production units." In addition, Cerbios has special partnerships in place that will help improve the productivity of the cell lines (at least 3-4 g/liter) received from Start-ups or Universities, including (1) gene synthesis, (2) cloning in an expression vector, and (3) transfection.

For partners already having a cell line with good productivity, the service provided by Cerbios R&D could include (1) cell line optimization, (2) process industrialization, and (3) GMP cell bank manufacturing prior to a move to GMP production for clinical trials.

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