Catalent has expanded its Limoges, France site to fulfil clinical biologics formulation development and drug product fill/finish services.

Contract development manufacturing organization (CDMO) Catalent announced its plans to invest $30 million in July 2020. Now, the firm has completed the project and says the Limoges plant will widen its global network, with clinical development through to clinical supply services and small-scale commercial manufacturing.

“Catalent continues to look for ways to support its customers as they advance projects to the clinic and on to commercial launch,” Bernie Clark VP of Marketing & Strategy at Catalent told BioProcess Insider.

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“This investment will serve large molecule programmes, and the company has responded to increased demand from customers to add dosage form development capabilities, and appropriate-scaled capacity as programmes progress to the clinic and launch. Limoges will also help facilitate the transfer of programmes from our early-phase drug substance facilities through to our large-scale commercial drug product facilities as those programmes look to scale-up and launch into the European Union.”

The CDMO has installed a small-to-mid-scale flexible filling line, which can handle vials, syringes, cartridges under barrier isolator technology, and improvements have been made to analytical and quality control laboratories that support clinical packaging, regulatory capabilities, and cold storage.

“France is one of the major producers of biopharmaceuticals in Europe, and the site’s location in Limoges benefits from being located within the Nouvelles Aquitaine region, which includes more than 250 industrial health players including universities and hospitals involved in health training and research, numerous patient associations, and a rich network of experts and support structures,” said Clark.

He continued: “The Limoges team will also work closely with Catalent’s other biologics sites in Anagni, Italy, Brussels, Belgium and in the US, to provide integrated clinical development and commercial manufacturing solutions across Europe.”

80 jobs

The 56,000 square-foot Limoges site currently employs over 170 members of staff and the CDMO says it expects the expansion to create around 80 additional jobs at the facility.

Clark said as several customers have committed programs to the site “hiring additional employees needed will be phased as we ramp up customer programs. We will also leverage our strong partnerships with local government and academic communities to attract top level talent in the area.”