French firm Novasep has significantly upped its capacity with a new high potency active pharmaceutical ingredient (HPAPI) plant at its facility in Le Mans, France.
The new €8m plant has already been installed and validated at the Le Mans facility, part of a €50m investment scheme at the site. According to a company spokesperson, the new plant allows the company to increase HPAPI capacity by around 50 per cent.
The new facility has been established in order to meet increasing demand for multipurpose chemistry and purification of HPAPIs in a confined good manufacturing practice (GMP) environment, according to Novasep.
Construction of the facility started at the end of 2006, with the plant able to cater for batches of up to 10kg.
The facility will allow the company to offer additional production capacity for late clinical and early commercial phase quantities manufactured under GMP conditions, following Novasep's plans to offer scale-up services for highly potent materials throughout their lifecycle.
According to a company spokesperson, there are already several contracts to make use of the facilities in advanced stages of discussion.
The new addition to the Le Mans site comes just months after Novasep announced the installation of a second kilo lab at the plant for synthesis and purification of highly potent substances. The new lab means that the firm can offer additional capacity for clinical phase quantities manufactured under GMP conditions.
The company believes its strength lies in its ability to mix well-known chemistry with new technologies, reducing the number of steps in a given HPAPI process to obtain pure but economically attractive molecules.
The Le Mans facility is the site of Novasep company Séripharm, the group's HPAPI specialist, with expertise in combining various techniques such as extraction, synthesis and semi-synthesis, preparative chromatography, crystallization and containments for HPAPIs up to Class 5.
The Novasep Synthesis arm of the company has particular expertise in cytotoxic products, and is one of the world's largest producers of paclitaxel and other taxanes.
This may not be the last chapter in Novasep's high potency growth, with a Novasep representative commenting that further expansions are indeed possible due to increasing market demand for its products.