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P'X news - 2005

• January 05. PX'Pharma SAS Approved by French agency AFSSAPS for the Biomanufacturing of Therapeutic Protein Candidates for Clinical trials.
PX’Pharma SAS announces that French agency AFSSAPS, which monitors the safety of medical products, has granted PX’Pharma a manufacturing authorization* for its cGMP ** facility based in Grenoble, Southeast France. The PX’Pharma manufacturing unit and quality assurance systems were inspected in October 2004.
PX’Pharma is authorized to contract manufacture and release therapeutic protein candidate batches to be used for preclinical and clinical trials by its customers. PX’Pharma will comply with the EU Clinical Trial Directive 2001/20/EC which is currently being transposed into French law.

PX’Pharma is one of the first biopharmaceutical manufacturers operating in France to be authorized to release cGMP-grade therapeutic protein candidates. PX’Pharma derives its specialist know-how of recombinant proteins from its parent company, the Protein’eXpert group, in order to accompany clients in their therapeutic protein developments toward industrial scale biomanufacturing. PX’Pharma will also be authorized to manufacture protein-based biopharmaceuticals which are fully developed and require small scale batches. A clinical batch of a therapeutic enzyme is currently being contract manufactured for a French pharmaceutical company.

* AFSSAPS grants PX’Pharma an “Etablissement Pharmaceutique” status.
** cGMP stands for “current Good Manufacturing Practices" – the standard to which biopharmaceuticals have to be manufactured.

PX'Pharma Profile

PX’Pharma is a 100% subsidiary of the Protein’eXpert SA group based in Grenoble, France. Protein’eXpert was set up in late 2000 to rapidly become one of Europe’s leading specialists of custom recombinant protein engineering and production for biomedical research.

PX’Pharma operates a state-of-the-art modular biomanufacturing facility in order to develop custom production processes and subsequently produce and purify therapeutic protein candidates used in preclinical and early-stage clinical trials. The facility operates on a production campaign mode and has been fully operational since Q4-2004. The facility is compatible with bacterial and yeast bioproduction systems.