Novasep unveiled plans for a €10 million investment in a commercial fill and finish facility for viral vectors, mAbs and other low-volume biologics. The facility will be located in Seneffe, Belgium and will be operational during the second half of 2019.

Fill and finish operations are critical to ensure the safety and efficacy of a drug. This step involves filling biologics into containers under aseptic conditions and is the final part of the biopharmaceutical manufacturing process, after upstream bioprocessing (cell culture) and downstream processing (purification).

The new Novasep plant will feature a fill and finish suite with state of the art filling equipment and isolators. It will deliver up to 10,000 vials per session, with two to three sessions per week. In line with its strategic development plan, the investment will allow Novasep to respond to the strong market demand for orphan and targeted biopharmaceutical drugs as clinical pipelines mature.

This project is part of Novasep’s Rise-2 strategic growth cycle. It complements a €27 million investment in a new commercial scale viral vector production facility in Seneffe that will be fully qualified by the first quarter of 2019, and a €17 million investment in a dedicated cGMP clinical scale mAb production facility that will be located in Pompey, France and will be commissioned in the second half of 2019.

“The trend towards targeted therapies has created a growing need for specialized capacities,” said Jean Bléhaut, president of Novasep’s manufacturing solutions business unit. “In response, Novasep has launched a series of major projects to boost its biomanufacturing services for selected types of drug substances and fill and finish activities.”

Michel Spagnol, chairman and chief executive officer, Novasep, said, “After the €17 million investment in our mAb production facility and the €27 million investment in gene therapy production, this is the third investment that we announce to support the strong development of innovative therapies. With this third investment, Novasep furthers its engagement to the RISE-2 strategic plan aimed at doubling the company’s size by 2022.”