GMP MANUFACTURE
In contrast to many medium-sized biotech companies which contract-out the manufacturing of clinical-grade material for clinical testing, Philogen believes that in-house manufacturing of lead compounds represents the best strategy for fast and successful product development.
Philogen’s production facilities are located in Siena (Italy). They consist of three adjacent buildings of nearly 2.000 square meters where more than 40 employees are occupied.
This state-of-the-art GMP unit has received authorization from the Italian Ministry of Health for the production of biopharmaceuticals for clinical studies.
The authorization is EMEA-wide valid in view of the mutual recognition agreement among the EC member states. All products manufactured in our facility can therefore be used for clinical trials in European hospitals.
Philogen scientists are experienced in the establishment of cell banks, process development and scale-up fermentation of cell lines expressing recombinant proteins.
 
Current overall production capacity enables Philogen to produce enough material to run Clinical Trials up to completion of Phase II. In certain cases where low doses per patient are needed (e.g. cytokine-based products), Phase III production campaigns are also feasible.

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