The tension on the market surrounding the lack of fill & finish capabilities is ‘visible,’ says Novasep as it pumps US$12 million into a site in Belgium.
The investment at Novasep’s site in Seneffe, Belgium will support the fill & finish for viral vectors, mAbs and other low-volume biologics.
According to Laure Saloin, a spokesperson from the French life sciences services firm, the €10 million (US$11.8 million) spend supports the “one-stop-shop approach for our monoclonal antibodies and our viral-vectors bulk offer,” and is not specific to a customer.
Saloin told BioProcess Insider the facility responds to the market demand for orphan and targeted biopharmaceuticals as clinical pipelines mature, and will help alleviate a lack of fill & finish capabilities both in Europe and globally.
“The tension on the market is visible and we believe it is not limited to Europe.”
She continued: “The trend towards targeted therapies has created a growing need for specialized capacities.” In response, Novasep has launched a series of projects to boost its biomanufacturing services for selected types of drug substances and fill & finish activities, with the Seneffe expansion being the latest.
The plant, set to be operational mid-2019, will have the capacity to deliver up to 10,000 vials per session, with up to three sessions per week.
“We consider this to match commercial requirements for gene therapy or small volumes mabs serving small populations of patients,” Saloin said.
Last December, the firm announced a €17 million investment at its Pompey, France cGMP monoclonal antibody manufacturing facility, offering small volume Mab production for targeted therapies, orphan indications, and antibody-drug conjugates (ADC).
And in February 2017, the contract manufacturing organization (CMO) invested €33 million in a new commercial viral vector production facility in Seneffe, set to be fully qualified by the first quarter 2019.