Pierre Fabre Medicament - Active Ingredients Division - Product Extraction and Purification - Cytotoxic API Manufacturing

Pierre Fabre Medicament - Active Ingredients Division (formerly known as Plantes & Industrie), a cGMP compliant Custom Manufacturing Organisation (CMO) of APIs, offers an extensive expertise in the areas of natural product extraction and purification, cytotoxic API manufacture and innovative drug delivery system.

From development, our skilled scientists identify and optimise the synthetic route of your API.

In parallel, we develop high performance analytical methods. The scaling-up and the optimisation of the process are then ensured at our fully equipped pilot plant. We can validate the process and manufacture your clinical batches. The process can be easily and rapidly transferred to our commercial production units. We prepare and fill all your regulatory dossiers for the FDA and EMEA submissions. Our site has never had any 483 form while FDA inspected.

NATURAL PRODUCT EXTRACTION

With 30 years of experience, Pierre Fabre Medicament is highly skilled in natural product extraction (plants or marine organisms). Our production areas, based in France and Argentina, are equipped with continuous extraction lines (up to 1,000kg/h) and horizontal batch extractors. More than 350 references (between 2,000t and 3,000t of different plants) are extracted and purified in our cGMP facilities.

INDUSTRIAL PURIFICATION - ISOLATE PURE SINGLE MOLECULES

In parallel, we have developed an extensive know-how in purification of complex mixtures to isolate pure single molecules (UF, Industrial HPLCs up to 450mm internal diameter). Furthermore, we have recently acquired the first industrial centrifugal partition chromatography apparatus. Based on the counter-current chromatography, this liquid/liquid chromatography enables us to purify small and high-molecular weight molecules. This technology offers many advantages compared to standard methods: no solid phase, no irreversible adsorption, quantities of solvent dramatically decreased and pH-based purification.

CYTOTOXIC APIS MANUFACTURE

Our second core-expertise is based on cytotoxic APIs handling. As Pierre Fabre Medicament is also the API manufacturing department of Pierre Fabre Laboratories, we manufacture Vinorelbine (Navelbine's API) and Vinflunine (Javlor's API) as well as other cytotoxic API for other partners. From lab to commercial scale, we have the capabilities to manufacture your high-potency APIs in our FDA approved facilities.

BIOAVAILABILITY ENHANCEMENT USING SUPERCRITICAL CO2

We also offer our partners an innovative technology to dramatically enhance bioavailability of APIs using SuperCritical CO2. In this area, two main systems have been developed: Nanocrystallisation Technologies (RESS and SAS) enabling us to increase the surface specific area of an API, and complexation with cyclodextrins (Pierre Fabre patented technology), allowing us to enhance solubility and stability of any kind of APIs. Solubility can be cost-effectively increased by up to 900 times. In September 2004, we have launched our state-of-the-art new facilities. Our development and production areas, equipped with a wide range of reactors (from 1g up to 20t API/year) have been designed to fit your needs and to handle non-toxic, toxic and cytotoxic APIs.

Pierre Fabre Medicament has been ISO 14001 certified since 1998 and awarded by the French Ministry of Environment for our efforts within environment protection.

MAIN PARTNERSHIPS

Pierre Fabre Medicament is currently manufacturing Vinorelbine, Navelbine's API marketed on the US market in partnership with GSK. Now in Phase III, Vinflunine should be soon marketed by BMS on US market. Minalcipran, anxiolytic drug, used in Fybriomyalgia, is developed in collaboration with Forest Laboratories and Cypress Biosciences.